Search the Community

We have evidently raised an entire generation of quasi "professionals" in the US who have no regard for the US Constitution, rights, rule of law or even a sense of propriety.

Copied as found. Don't know how true this is. APRIL 10, 2020 On Wednesday, the U.S. Food and Drug Administration issued a statement regarding an experimental treatment for COVID-19. It involved “convalescent plasma” collected from people who have recovered from the disease. The FDA said that, while the treatment had not been approved (since experimental data was virtually non-existent), there were a few places where scientists or doctors could use it, including in patients with “serious or immediately life-threatening COVID-19 infections.” The thinking is that there are antibodies present in the plasma of recovered patients that could help current patients fight the virus. Okay. Fine. The problem is that the Jehovah’s Witnesses are reacting to this statement by saying it would violate the religion’s rules to accept this treatment. JWs have famously refused blood transfusions since 1945 even when they’re needed to save their own lives. The religion’s leaders are now saying plasma is included in that ban. The watchdog site JWsurvey obtained a “leaked memo from a Jehovah’s Witness Circuit Overseer” sent to local leaders: Do you think ALMIGHTY GOD really means this ?

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

(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." https://edition.cnn.com/2018/11/01/health/marijuana-drug-epidiolex-prescription/index.html

(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." https://amp.cnn.com/cnn/2018/11/02/health/new-opioid-dsuvia-fda-approval-bn/index.html

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. https://www.nytimes.com/2018/05/17/health/migraines-prevention-drug-aimovig.html

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. https://www.nbcnews.com/health/health-news/sunscreen-pills-are-fake-medicine-fda-says-n876626

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? Source: http://nymag.com/scienceofus/2016/06/the-fda-just-approved-a-new-device-that-literally-sucks-food-out-of-your-stomach.html