Guest Nicole -
Guest Nicole -
By Health and Medicine
We don't say this often: It's been a wild month at the FDA. Fresh off its e-cig regulations, the agency announced yesterday it's going to overhaul the procedure for approving most medical devices.
Critics have waited a long time for this. The FDA currently operates under a framework from 1976, which allows certain devices to get a speedy, TSA PreCheck-type approval if manufacturers show their products are similar to others that already exist on the market.
The problem? Those comparable products (you can call them "predicates") are sometimes decades-old. The data: Nearly 20% of devices cleared through this process are based on predicates that have been around more than 10 years, per the FDA. Zoom out: Just a few days ago, a team of over 50 media organizations published an investigation into medical device safety. What did they find? "More than 1.7 million injuries and nearly 83,000 deaths suspected of being linked to medical devices had been reported to the U.S. Food and Drug Administration over a 10-year period."
VIA Morning Brew
By Guest Nicole
(CNN)Epidiolex, the first cannabis-based medication approved by the US Food and Drug Administration, is now available by prescription in all 50 states.
The twice-daily oral solution is approved for use in patients 2 and older to treat two types of epileptic syndromes: Dravet syndrome, a rare genetic dysfunction of the brain that begins in the first year of life, and Lennox-Gastaut syndrome, a form of epilepsy with multiple types of seizures that begins in early childhood, usually between ages 3 and 5.
"Because these patients have historically not responded well to available seizure medications, there has been a dire need for new therapies that aim to reduce the frequency and impact of seizures," said Justin Gover, CEO of GW Pharmaceuticals, the maker of Epidiolex, in a written statement. "We are committed to ensuring that these patients can access this novel cannabinoid medicine that has been thoroughly studied in clinical trials, manufactured to assure quality and consistency, and is eligible to be covered by insurance for appropriate patients."
By Guest Nicole
(CNN)Despite the ongoing opioid crisis plaguing the nation, the US Food and Drug Administration on Friday approved a new opioid medication five to 10 times more powerful than fentanyl.
Dsuvia, made by AcelRx Pharmaceuticals Inc., is a tablet in a single-dose, prefilled applicator to be administered under the tongue by health care providers to patients in settings such as hospitals, surgical centers and emergency rooms, according to the company.
FDA Commissioner Dr. Scott Gottlieb was quick to defended the approval in a statement Friday: "The agency is taking new steps to more actively confront this crisis, while also paying careful attention to the needs of patients and physicians managing pain."
By Guest Nicole
We are concerned about reports of canine heart disease, known as dilated cardiomyopathy (DCM), in dogs that ate certain pet foods containing peas, lentils, other legumes or potatoes as their main ingredients. These reports are highly unusual as they are occurring in breeds not typically genetically prone to the disease,” said Martine Hartogensis, D.V.M., deputy director of the FDA’s Center for Veterinary Medicine’s Office of Surveillance and Compliance. “The FDA is investigating the potential link between DCM and these foods. We encourage pet owners and veterinarians to report DCM cases in dogs who are not predisposed to the disease.”
The U.S. Food and Drug Administration’s Center for Veterinary Medicine and the Veterinary Laboratory Investigation and Response Network, a collaboration of government and veterinary diagnostic laboratories, are investigating the potential association between reports of canine dilated cardiomyopathy (DCM) in dogs and certain pet foods the animals consumed, containing peas, lentils, other legume seeds or potatoes as main ingredients. Canine DCM is a disease of a dog’s heart muscle and often results in congestive heart failure. In cases that are not linked to genetics, heart function may improve with appropriate veterinary treatment and dietary modification if caught early.
By Guest Nicole
The first medicine designed to prevent migraines was approved by the Food and Drug Administration on Thursday, ushering in what many experts believe will be a new era in treatment for people who suffer the most severe form of these headaches.
The drug, Aimovig, made by Amgen and Novartis, is a monthly injection with a device similar to an insulin pen. The list price will be $6,900 a year, and Amgen said the drug will be available to patients within a week.
Aimovig blocks a protein fragment, CGRP, that instigates and perpetuates migraines. Three other companies — Lilly, Teva and Alder — have similar medicines in the final stages of study or awaiting F.D.A. approval.
By Guest Nicole
There’s no such thing as a sunscreen pill, the Food and Drug Administration said Tuesday, telling companies that sell them to stop.
These so-called sunscreen-in-a-pill supplements are fakes and people should not fall for the scam, the FDA said.
“There’s no pill or capsule that can replace your sunscreen,” FDA commissioner Dr. Scott Gottlieb said in a statement on Tuesday.
By Guest Nicole
Although the rising pandemic of obesity has received major attention in many countries, the effects of this attention on trends and the disease burden of obesity remain uncertain.
Read more: http://www.nejm.org/doi/full/10.1056/NEJMoa1614362?query=featured_home&
By Guest Nicole
Obesity and weight problems are on the rise across the world, according to a new study. In fact, more than 2 billion adults and children (or more than 30 percent of the world’s population) suffered from health problems stemming from being overweight or obese in 2015, and more people than ever are dying because of weight-related problems, the study found.
Published in the New England Journal of Medicine, the study analyzed data from 195 countries between 1980 and 2015, collected as part of the Global Burden of Disease study (which looked at the health loss of more than 300 diseases and injuries). Scientists from the University of Washington found that more than 107 million children and 603 million adults worldwide were obese as of 2015, and even more are technically overweight. And in the U.S. alone, 79 million adults were technically obese in 2015, as compared to 57 million adults in China (which has four times as many people as the U.S.), the Associated Press notes. The U.S. also has the highest number of overweight or obese young adults or children.
Read more: http://nymag.com/scienceofus/2017/06/obesity-overweight-global-population-study.html
By Guest Nicole
It’s pretty obvious that carrying around extra weight can make you feel sluggish, affect your self-esteem and put you at increased risk for heart disease and diabetes. But increasingly, researchers are also making connections between obesity and cancer—several different types of cancer, in fact.
Cancer is caused by mutations within cells, which cause those cells to grow and multiply at unnatural rates. Many cases of cancer occur because of genetic traits, or purely because of chance. But for others, obesity can be a big contributing factor.
“We know that a good third of cancers are associated with our lifestyle behaviors, such as what we eat, how much we exercise, and collectively, our weight,” says Melinda Irwin, director of Cancer Prevention and Control at Yale University. “And obesity is now the leading modifiable risk factor, even ahead of tobacco use, that’s associated with cancer risk and mortality.”
How does obesity encourage cancer growth?
High-levels of long-term inflammation—the immune system’s response to injury, illness, or other disturbances in the body—has been shown to fuel the growth of cancer cells. “And we know that obesity is basically a chronic inflammatory state,” says Irwin.
Not only can obesity itself trigger inflammation; so can some of the the eating behaviors that lead to weight gain in the first place—like high-sugar and high-fat diets. Having too much fat around the belly, regardless of body mass index, increases inflammation in the body, as well.
Some cancers are also linked to sex hormones like estrogen. Women’s bodies produces estrogen in their fat cells, especially after menopause. “The higher levels of body fat you have, the higher levels of estrogen,” says Irwin.
Then there’s the way that obesity contributes to insulin resistance—a condition in which the body loses its sensitivity to the hormone and can’t respond normally. This can lead to excess levels of insulin and insulin-related growth hormones in the body, which has been linked to cell proliferation and several types of cancer.
By Guest Nicole
France has banned restaurants from offering unlimited refills of soda and sugary drinks, the latest bid to decrease the rise in the nation's obesity rate.
The new order, implemented on Jan. 27, will mean that hotels, restaurants and school cafeterias will no longer have soda fountains. The move is part of a spate of health initiatives implemented by the country, which includes a "soda tax" imposed on sweetened drinks, a ban on vending machines in schools and a limit on the servings of french fries to once a week in schools, the New York Times reports.
Even though France's overall obesity rate is relatively low—41% of women and 57% of men between 30 to 60 were obese or overweight—the laws are in accordance with World Health Organization (WHO) recommendations. WHO presented statistics in 2016 on the good effects of imposing a sugar tax.
By Guest Nicole
A large study has found that body mass index, waist circumference and diabetes are all associated with an increased risk for liver cancer. Liver cancer is the sixth most common cancer, and its incidence has tripled since the mid-1970s in the United States.
For the study, in Cancer Research, researchers pooled data from 14 prospective studies with more than 1.5 million participants. After controlling for age, sex, alcohol use, smoking and race, they found that being overweight increased the relative risk for liver cancer by between 21 percent and 142 percent as B.M.I. increased. For each 2-inch increase in waist circumference, the risk of liver cancer increased by 8 percent, even after controlling for B.M.I. And those with Type 2 diabetes had more than double the risk of liver cancer, even among the non-obese.
There was no association of B.M.I. with cancer if the patient had hepatitis, a cause of liver cancer so strong that it overwhelms any other cause. But among those without hepatitis, the increased risk was significant.
“This study underscores that the parallel increase in obesity is part of the increase in liver cancer rates,” said the lead author, Peter T. Campbell, an epidemiologist with the American Cancer Society. “Now we have to accept the fact that obesity and Type 2 diabetes are strongly associated with liver cancer.”
By Guest Nicole
WEDNESDAY, Aug. 10, 2016 (HealthDay News) -- Could too much weight be bad for the brain as well as the belly?
New research suggests that being overweight or obese may trigger premature aging of the middle-aged brain.
The study centered on how carrying excess weight might affect the brain's white matter, which facilitates communication between different brain regions.
White matter tissue is known to shrink with age. But the new study found that the amount of white matter in the brain of a 50-year-old overweight/obese person was comparable to that of a 60-year-old lean person.
"Obesity is associated with a host of biological processes that are seen in normal aging," said study author Lisa Ronan, a research associate in the department of psychiatry at the University of Cambridge in England. "And therefore we hypothesized that obesity may in fact compound the effects of aging that we see in the brain. This is what we found."
Ronan stressed that it's "too early to tell" what this really means. "However, it is possible that being overweight may raise the risk of developing disorders related to neurodegeneration such as Alzheimer's disease or dementia," she said.
Still, the study didn't prove obesity causes premature brain aging. And, Ronan noted that "there were no differences in cognitive ability between overweight and obese people and their lean counterparts."
Ronan and her colleagues focused on nearly 500 men and women between the ages of 20 and 87. All were residents of the Cambridge region and in good mental health.
About half were "lean" (at a body mass index or BMI between 18.5 and 25). Nearly a third were "overweight" (BMI 25 to 30), and about 20 percent were "obese" (BMI over 30). Body mass index is a measure of body fat based on weight in relation to height.
Initial white matter measurements generally revealed that overweight/obese participants had notably reduced white matter volume compared with lean participants.
And an age breakdown revealed that a middle-aged participant who was either overweight or obese had a white matter volume comparable in size to that of a middle-aged lean participant a decade older.
The study authors stressed that the 10-year white matter difference was only seen among those middle-aged and older, not among participants in their 20s or 30s. This, they said, suggests that the brain may become increasingly vulnerable to the impact of excess weight as people grow older.
"At the moment, we really don't know what might be driving the correlation between an increased BMI and lower white matter volume," noted Ronan.
"Indeed, it is not yet clear whether being overweight/obese may cause brain changes, or whether brain changes may in some way cause an increase in adiposity (excess weight)," she added.
"Until we understand the mechanism that relates BMI to brain changes, it is not easy to say whether losing weight will in some way act to mitigate the effects we reported," she said. "This is something that we are currently investigating."
The findings were published recently in the Neurobiology of Aging journal.
Dr. Yvette Sheline is director of the Center for Neuromodulation in Depression and Stress at the University of Pennsylvania's Perelman School of Medicine. She described Ronan's study as "interesting from several perspectives."
But, Sheline noted that the study had a few "limitations," which might explain why the research team didn't observe any relationship between reduced white matter volume and poorer memory and thinking.
Sheline said Ronan's team "only looked at obesity as an overall measure and didn't take into account the distribution of fat." She also noted that some studies have suggested that obesity centered around the waist does tend to have a worse effect on thinking than other types of obesity.
"Also, this study didn't actually follow people over time, so their conclusions are limited by having measures from only one time point," Sheline added.
There's more on obesity's impact on health at the U.S. National Heart, Lung, and Blood Institute.
SOURCES: Lisa Ronan, Ph.D., research associate, department of psychiatry, University of Cambridge, Cambridge, England; Yvette Sheline, M.D., professor, psychiatry, radiology and neurology, and director, Center for Neuromodulation in Depression and Stress, University of Pennsylvania Perelman School of Medicine, Philadelphia; July 27, 2016, Neurobiology of Aging
Last Updated: Aug 10, 2016
By Guest Nicole
THURSDAY, March 31, 2016 (HealthDay News) -- More people worldwide are obese than underweight, a new study found.
The researchers added that about one-fifth of adults could be obese by 2025.
The number of obese people in the world rose from 105 million in 1975 to 641 million in 2014, with obesity rates rising from 3 percent to 11 percent among men and from 6 percent to 15 percent among women, the study found.
Over the same time, the proportion of underweight people fell from 14 percent to 9 percent of men and from 15 percent to 10 percent of women, according to the study.
More than one-quarter of severely obese men and nearly one-fifth of severely obese women in the world live in the United States, the researchers said.
On average, people worldwide have become an average of 1.5 kilograms (3.3 pounds) heavier each decade. At the current pace, about 18 percent of men and 21 percent of women will be obese, and more than 6 percent of men and 9 percent of women will be severely obese by 2025, the study found.
The findings were released online on March 31 in The Lancet.
"Over the past 40 years, we have changed from a world in which underweight prevalence was more than double that of obesity, to one in which more people are obese than underweight," said study senior author Majid Ezzati, a professor at Imperial College London's School of Public Health, in England.
"If present trends continue, not only will the world not meet the obesity target of halting the rise in the prevalence of obesity at its 2010 level by 2025, but more women will be severely obese than underweight by 2025," he said in a journal news release.
"To avoid an epidemic of severe obesity, new policies that can slow down and stop the worldwide increase in body weight must be implemented quickly and rigorously evaluated, including smart food policies and improved health care training," Ezzati said.
Despite the findings, extremely low weight remains a serious public health problem in the poorest parts of the world, the researchers noted. For example, nearly one-quarter of people in south Asia are underweight, as are 15 percent of men and 12 percent of women in central and east Africa.
The study findings reflect "a fatter, healthier but more unequal world," wrote George Davey Smith in an accompanying journal editorial. He is a professor of clinical epidemiology at the University of Bristol, in England.
"A focus on obesity at the expense of recognition of the substantial remaining burden of undernutrition threatens to divert resources away from disorders that affect the poor to those that are more likely to affect the wealthier in low-income countries," he noted.
The U.S. National Institute of Diabetes and Digestive and Kidney Diseases outlines thehealth risks of being overweight.
SOURCE: The Lancet, news release, March 31, 2016
By Guest Nicole
They are renowned for meditation and moderation, but more than half the country’s Buddhist monks are obese, according to new research.
The early morning alms round by saffron-clad monks holding their donations bowls to collect food and drink is a familiar daily ritual in Thailand.
But scientists have now concluded that the tradition is contributing to anobesity epidemic among the Buddhist monkhood.
For according to a startling new study, nearly half the country’s monks are obese and suffering related health problems such as high blood pressure, diabetes and high cholesterol.
The expanding waistlines are largely filling out because of the donations to their daily diet, researchers concluded. For the alms often consist of drink juices, sweet tea, snacks and street foods – all laden with fat and sugar.
The largely sedentary nature of temple monastic life – with large amounts of time spent in prayer and meditation – is also exacerbating the health woes.
Academics and religious and heath officials and academics have now launched a new campaign to promote leaner clerical living by weaning monks off unhealthy food, teach them how to prepare nutritional balanced meals and encouraging them to exercise.
The aim is to help the monks lead longer healthier lives and also to reduce medical fees as the the government covers such costs for members of the clergy.
Jongjit Angkatavanich, a health and nutrition expert at Bangkok's prestigious Chulalongkorn University, said the study showed that 48 per cent of monks are obese.
"Obesity in our monks is a ticking time bomb," she told the Bangkok Post. Her study found 42 per cent of monks have high cholesterol levels, 23 per cent suffer from high blood pressure, and more than 10% are diabetic.
Although there has been disagreement about measures of obesity, the increasing challenge of overweight monks is not in doubt.
The university’s Faculty of Allied Heath Sciences university has teamed up with religious organisations to launch a national programme to combat monk obesity.
They have already started a trial project to train cooks and officials at Mahachulalongkornrajavidyalaya University, one of Thailand’s two public Buddhist universities.
The emphasis was on preparing meals with added protein, fibre and calcium and encouraging monks to increase their physical activity.
The results were immediate. Among 82 monks with obesity problems who were attending religious programmes at the college, the clerics lost 2.2 pounds (1kg) on average and reduced their waistlines by more than half an inch during the eight-week programme. One monk said that he shed as much as 22 pounds (10 kgs).
Chulalongkorn Medical Hospital has also provided monks with a specially-designed girdle to wear so that they feel the squeeze if they over-eat and gain weight.
The obesity phenomenon is another blow to the image of a religious institution whose members are supposed to have opted for lives of austerity, meditation and asceticism, eschewing materialism and excess.
Several financial, sexual and jet-set lifestyle scandals and have embroiled senior clerics in recent years in a country that is 90 per cent Buddhist.
And Thai Buddhism does not currently have a spiritual leader as the appointment of a new Supreme Patriarch has been caught up in another long-running controversy.
The confirmation of the 90-year-old abbot nominated by the supreme clerical council has been ensnared in an investigation of an alleged tax evasions scam involving a vintage car and his links to a controversial temple.
The stand-off developed into remarkable clashes between monks and soldiers as supporters of the abbot, Somdet Chuang, tried to stage a protest in his favour.
The cleric is being investigated for allegedly acquiring a vintage Mercedes-Benz through a tax evasion scheme. He has denied any wrongdoing.
But he is also associated with the Dhammakaya sect that is under scrutiny for allegedly amassing a fortune as well as ties to the deposed ex-prime minister, Thaksin Shinawatra.
Thailand’s ruling junta, which overthrew Mr Thaksin’s sister Yingluck as prime minister in 2014, has delayed seeking the required endorsement of the ailing King Bhumipol to confirm Somdet Chuang to the country’s highest religious position.
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