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
As summers grow steadily hotter, many people feel a need to slather on ever more sunscreen—or wear more clothes—to prevent the sun’s ultraviolet radiation from crisping their skin and increasing the odds of developing cancer. But scientists may have found a new way to block these dangerous rays: melanin-imitating nanoparticles that protect skin cells from within. If proved, this approach could be used to develop better topical protection and possibly treatments for certain skin disorders as well.
The darkening pigment melanin is one of the body’s primary natural defenses against UV-induced DNA damage. Below the skin’s surface, special cells secrete melanosomes, which produce, store and transport melanin. These structures are absorbed by skin cells called keratinocytes and form protective, UV-blocking shells around the cells’ nuclei. People suffering from diseases such as albinism and vitiligo, however, have faulty melanin production and are highly susceptible to the effects of UV.
To create synthetic versions of these melanosomes, researchers at the University of California, San Diego, bathed dopamine—a signaling chemical found in the brain and other parts of the body—in an alkaline solution. This step produced melaninlike nanoparticles with shells and cores made of polydopamine, a dopamine-based polymer. When incubated in a petri dish with human keratinocytes, the synthetic particles were absorbed by the skin cells and distributed around their nuclei like natural melanin.
Read more: https://www.scientificamerican.com/article/synthetic-ldquo-melanin-rdquo-could-act-as-a-natural-sunscreen/
Widespread vitamin D deficiency likely due to sunscreen use, increase of chronic diseases, review finds Date:By Guest Nicole
May 1, 2017
American Osteopathic Association
Results from a clinical review find nearly 1 billion people worldwide may have deficient or insufficient levels of vitamin D due to chronic disease and inadequate sun exposure related to sunscreen use.
Results from a clinical review published in The Journal of the American Osteopathic Association find nearly 1 billion people worldwide may have deficient or insufficient levels of vitamin D due to chronic disease and inadequate sun exposure related to sunscreen use.
The study also found that 95 percent of African American adults may have vitamin D deficiency or insufficiency. Vitamin D variations among races are attributed to differences in skin pigmentation.
"People are spending less time outside and, when they do go out, they're typically wearing sunscreen, which essentially nullifies the body's ability to produce vitamin D," said Kim Pfotenhauer, DO, assistant professor at Touro University and a researcher on this study. "While we want people to protect themselves against skin cancer, there are healthy, moderate levels of unprotected sun exposure that can be very helpful in boosting vitamin D."
Dr. Pfotenhauer also said chronic diseases like Type 2 Diabetes and those related to malabsorption, including kidney disease, Crohn's and celiac disease greatly inhibit the body's ability to metabolize vitamin D from food sources.
Considered a hormone rather than a vitamin, vitamin D is produced when skin is exposed to sunlight. Vitamin D receptors are found in virtually every cell in the human body. As a result, it plays a wide role in the body's functions, including cell growth modulation, neuromuscular and immune function and inflammation reduction.
Symptoms for insufficient or deficient vitamin D include muscle weakness and bone fractures. People exhibiting these symptoms or who have chronic diseases known to decrease vitamin D, should have their levels checked and, if found to be low, discuss treatment options. However, universal screening is likely neither necessary nor prudent absent significant symptoms or chronic disease.
Increasing and maintaining healthy vitamin D levels can be as easy as spending 5-30 minutes in midday sun twice per week. The appropriate time depends on a person's geographic location and skin pigmentation -- lighter skin synthesizes more vitamin D than darker skin. It is important to forgo sunscreen during these sessions because SPF 15 or greater decreases vitamin D3 production by 99 percent.
"You don't need to go sunbathing at the beach to get the benefits," said Dr. Pfotenhauer. "A simple walk with arms and legs exposed is enough for most people."
Food sources such as milk, breakfast cereals, and Portobello mushrooms are also fortified with vitamin D. Dr. Pfotenhauer said supplements are a good option, as they are effective and pose few risks, provided they are taken as directed and a physician is consulted beforehand.
Research is ongoing to determine whether vitamin D deficiency has a role in multiple sclerosis, autoimmune disorders, infections, respiratory disease, cardiometabolic disease, cancer, and fracture risk.
"Science has been trying to find a one-to-one correspondence between vitamin D levels and specific diseases," said Dr. Pfotenhauer. "Given vitamin D's ubiquitous role in the body, I believe sufficient vitamin D is more about overall health. Our job as osteopathic physicians is to recognize those patients that need to be tested and treat them accordingly."
Currently, insufficiency is defined as between 21 and 30 ng/ml and deficiency is considered below 20ng/ml by the Endocrine Society.
By Guest Nicole
Today, the U.S. Food and Drug Administration approved a new device that would help obese people absorb fewer calories — by draining a portion of their undigested stomach contents directly into the toilet.
The AspireAssist is basically a small pump that attaches to a hose surgically implanted in a person’s stomach. Twenty to 30 minutes after every meal, they’d open the port valve, turn on the device, and pump out about 30 percent of the food they ate. The process takes five to ten horrifying minutes.
In a yearlong clinical trial, people treated with an AspireAssist device and nutrition and exercise counseling lost an average of 12.1 percent of their body weight versus 3.6 percent in a control group that received the counseling alone.
It’s meant for people age 22 and over with a body mass index between 35 and 55 — obesity is technically a BMI of 30 or more — who haven’t responded to other non-surgical weight-loss approaches. Last week, federal health officials announced that 38 percent of adults are obese.
But, the FDA warns, the device “should not be used on patients with eating disorders.” Perhaps that’s because critics say it mimics binge-and-purge behavior. In 2013, a nutrition professor characterized the device as a “bulimia machine.”
The FDA also writes that “patients require frequent monitoring by a health care provider to shorten the tube as they lose weight and abdominal girth, so that the disk remains flush against their skin.” Side effects of the device include occasional indigestion, nausea, vomiting, constipation, and diarrhea plus “leakage, bleeding and/or infection around the site where the tube is placed and device migration into the stomach wall.”
Wait, I’m sorry: Someone thought this was an advancement in the treatment of obesity?
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