Eli Lilly (NYSE: LLY) reportedly paused a clinical trial testing its COVID-19 antibody treatment candidate because of a “potential safety concern.”
The New York Times reported that Eli Lilly’s testing site researchers were notified of the pause by emails sent by government officials (it is a government-sponsored trial) and the company later confirmed it. A spokesperson from the company told The Hill that “Safety is of the utmost importance to Lilly. We are aware that, out of an abundance of caution, the ACTIV-3 independent data safety monitoring board (DSMB) has recommended a pause in enrollment.”
Eli Lilly’s trial was comparing its therapy to a placebo, while all study participants also received the experimental drug remdesivir, which has been used in treating COVID-19 throughout the pandemic. The company’s therapeutic uses monoclonal antibodies in an effort to block the virus from infecting cells.
GE Healthcare has received 510k clearance from US FDA for its Ultra Edition package on Vivid cardiovascular ultrasound systems, which come with features based on artificial intelligence (AI) that allows clinicians to get quicker and more exams repeatedly. Although methodical evaluations of heart function are necessary in echocardiography, such evaluations can be time-consuming and difficult to get. Quality acquisition of data and operator skill are essential factors to get precise and thorough exams. Given that patients undergo subsequent monitoring exams, the reproducibility of the exam evaluations is essential to monitoring improvement or progress of the disease.
Flexible spikes
The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein enables viral entry into host cells by binding to the angiotensin-converting enzyme 2 (ACE2) receptor and is a major target for neutralizing antibodies. About 20 to 40 spikes decorate the surface of virions. Turoňová et al. now show that the spike is flexibly connected to the viral surface by three hinges that are well protected by glycosylation sites. The flexibility imparted by these hinges may explain how multiple spikes act in concert to engage onto the flat surface of a host cell.
Science, this issue p. 203.
By Beata Turoňová, Mateusz Sikora, Christoph Schürmann, Wim J. H. Hagen, Sonja Welsch, Florian E. C. Blanc, Sören von Bülow, Michael Gecht, Katrin Bagola, Cindy Hörner, Ger van Zandbergen, Jonathan Landry, Nayara Trevisan Doimo de Azevedo, Shyamal Mosalaganti, Andre Schwarz, Roberto Covino, Michael D. Mühlebach, Gerhard Hummer, Jacomine Krijnse Locker, Martin Beck.
If Dr. Ken Berry actually meant to say that you need to eat saturated fat for your nerves and brain, he flunks Biochem 101. First of all, your body can make all the saturated fat you need out of carbs and proteins. You don’t need to eat ANY saturated fat. Second, the most common fatty acid in your brain is the polyunsaturated fatty acid (PUFA) called DHA, which you DO need to eat, because you can’t make it from non-fats (you need to eat it or EPA in things like seafood, or at least the precursor omega-3 PUFA called ALA in cold-climate plants.) Ironically enough, ALA is common in Canola oil, which Dr. Berry deprecates, but not in the tropical plant oils that he likes. More on that later.
A diet with a lot of saturated fat is NOT the best for the heart. The American Heart Association continues to recommend low saturated fat diets (with the missing sat-fat replaced by mono and polyunsaturated fat, not by carbohydrates) because the evidence from animal and human trials and even properly controlled epidemiology, shows these the best diets (see reference below—an extensive review of meta analyses [1]). Examples are the DASH hypertension diet and the closely-related Mediterranean diet (which has lots of olive oil for monounsaturated fatty acid, and seafood for DHA). If Dr. Berry thinks he has something better than the Mediterranean diet for longevity, what is his direct evidence?
Saturated fat, of course, is used by the body to make cholesterol (you don’t need to eat any cholesterol for this reason), and it does raise cholesterol levels and it does increase atherosclerosis in nearly every controlled prospective experimental model in animals and humans. This is the gold standard of evidence in medicine.
One can go only so far with epidemiology, because occasionally when one bad thing (saturated fat) is heavily replaced for calories by another bad thing (certain carbohydrates) one detects no epidemiologic effect from changing just the first thing.
That happens with various high and low saturated fat diets around the world enough to make saturated fat look benign as a single input variable. It is not. Rather, what these studies really show is that replacing butter with sugar or high glycemic carbs gives you a diet equally bad for the arteries. One cannot see how bad that is, until one compares these with low-carbohydrate, low-saturated-fat diets, which are less common, but better. The double-negative tradeoff of carbs and saturated fats (where carbs are a statistical “confounder”) is one of those occasional cruel misdirectional things that happen with imperfectly controlled past-observations, but (again) it’s why biomedical knowledge consists of more than just epidemiology.
The saturated oils Dr. Berry recommends are by themselves on the edge of PUFA deficiency. This can be dramatic: for example the only way I know to give dogs atherosclerosis nutritionally, is to feed them just coconut oil for fat, and NO monounsaturates or PUFA. Apparently a little PUFA is extremely important for the heart, and larger amounts do no harm. There are hints that high PUFA diets are risks for certain cancers, but that merely underscores the need to get monounsaturates like olive and Canola where one can, and some PUFA foods. I know of no civilization that eats a lot of coconut oil that doesn’t eat seafood as well, so that combination is safe.
Canola oil is merely rapeseed oil bred to remove erucic acid and other potential toxins. It is high in monounsaturates and ALA and of all the plant oils is probably closest to optimal for human nutrition. Olive oil is probably better than Canola for frying, since ALA will oxidize, but Canola’s ALA is very important for vegans who need an omega-3 PUFA plant oil to convert to brain DHA. Seafood and olive oil are a fine replacement for Canola, but the person who cannot eat meat or seafood had better look for a baking and salad oil with ALA in it, and Canola oil is the best for this. Linseed oil is hard to digest and hard to work with, so that leaves Canola as the best omega-3 alternative for vegans. Dr. Berry never mentions his problem with Canola beyond saying it is GMO. But he is wrong there, as it doesn’t have to be. Canola as a product (1970’s) was created with hybrid not GMO techniques, and although GMO Canolas exist now, there also exist certified non-GMO and “organic” Canola oils which are labeled with a butterfly and tested to make sure no GMO Canola has crept in (there are tests available for this too complicated to go into here, but you can be sure).
If Dr. Ken Berry actually meant to say that you need to eat saturated fat for your nerves and brain, he flunks Biochem 101. First of all, your body can make all the saturated fat you need out of carbs and proteins. You don’t need to eat ANY saturated fat. Second, the most common fatty acid in your brain is the polyunsaturated fatty acid (PUFA) called DHA, which you DO need to eat, because you can’t make it from non-fats (you need to eat it in things like seafood, or at least the precursor omega-3 PUFA called ALA in cold-climate plants.) Ironically enough ALAis common in Canola oil, which Dr. Berry deprecates, but not in the tropical plant oils he likes. More on that later. A diet with a lot of saturated fat is NOT the best for the heart. The American Heart Association continues to recommend low saturated fat diets (with the missing sat-fat replaced by mono and polyunsaturated fat, not by carbohydrates) because the evidence from animal and human trials and even properly controlled epidemiology, shows these the best diets (see reference below–an extensive review of meta analyses [1]). Examples are the DASH hypertension diet and the closely-related Mediterranean diet (which has lots of olive oil for monounsaturated fatty acid, and seafood for DHA). If Dr. Berrythinks he has something better than the Mediterranean diet for longevity, what is his direct evidence? Saturated fat, of course, is used by the body to make cholesterol (you don’t need to eat any cholesterol for this reason), and it does raise cholesterol levels and it does increase atherosclerosis in nearly every controlled prospective experimental model in animals and humans. This is the gold standard of evidence in medicine.
One can go only so far with epidemiology, because occasionally when one bad thing (saturated fat) is heavily replaced for calories by another bad thing (certain carbohydrates) one detects no epidemiologic effect from changing just the first thing.
That happens with various high and low saturated fat diets around the world enough to make saturated fat look benign as a single input variable. It is not. Rather, what these studies really show is that replacing butter with sugar or high glycemic carbs gives you a diet equally bad for the arteries. One cannot see how bad that is, until one compares these with low-carbohydrate, low-saturated-fat diets, which are less common, but better. The double-negative tradeoff of carbs and saturated fats (where carbs are a statistical “confounder”) is one of those occasional cruel misdirectional things that happen with imperfectly controlled past-observations, but (again) it’s why biomedical knowledge consists of more than just epidemiology. The saturated oils Dr. Berryrecommends are by themselves on the edge of PUFA deficiency. This can be dramatic: for example the only way I know to give dogs atherosclerosis nutritionally, is to feed them just coconut oil for fat, and NO monounsaturates or PUFA. Apparently a little PUFA is extremely important for the heart, and larger amounts do no harm. There are hints that high PUFA diets are risks for certain cancers, but that merely underscores the need to get monounsaturates like olive and Canola where one can, and some PUFA foods. I know of no civilization that eats a lot of coconut oil that doesn’t eat seafood as well, so that combination is safe. Canola oil is merely rapeseed oil bred to remove erucic acid and other potential toxins. It is high in monounsaturates and ALAand of all the plant oils is probably closest to optimal for human nutrition. Olive oil is probably better than Canola for frying, since ALAwill oxidize, but Canola’s ALA is very important for vegans who need an omega-3 PUFA plant oil to convert to brain DHA. Seafood and olive oil are a fine replacement for Canola, but the person who cannot eat meat or seafood had better look for a baking and salad oil with ALA in it, and Canola oil is the best for this. Linseed oil is hard to digest and hard to work with, so that leaves Canola as the best omega-3 alternative for vegans. Dr. Berry never mentions his problem with Canola beyond saying it is GMO. But he is wrong there, as it doesn’t have to be. Canola as a product (1970’s) was created with hybrid not GMO techniques, and although GMO Canolas exist now, there also exist certified non-GMO and “organic” Canola oils which are labeled with a butterfly and tested to make sure no GMO Canola has crept in (there are tests available for this too complicated to go into here, but you can be sure).
In short, the ONLY part of Dr. Berry’s piece I agree with is dumping your hydrogenated shortening products (Crisco, etc.) in the garbage. That’s why I give this segment a D, rather than the F it otherwise deserves.
Steven B. Harris, M.D.
The 2 Gig service is targeting households with heavy internet users who are now forced to work from home due to COVID-19. “So we’re more than a little excited to announce 2 Gig today—bringing even more bandwidth and speed to customers in internet-intensive households who may need more than a gig to do their thing, whatever that may be,” wrote Amalia O’Sullivan, Google Fiber’s director of product management, in the announcement. (That said, upload speeds will remain at 1Gbps.)
Google Fiber is currently looking for subscribers in Nashville, Tennessee, and Huntsville, Alabama, to sign up as testers for the 2 Gig service. The beta will then roll out to other Google Fiber cities in the fall before the official launch. Interested customers can also go to the Google Fiber website to sign up for email updates on the 2Gbps service’s availability.
We should save their DNA and resurrect them or keep in a bubble environment.
Close To Home
The researchers behind the study warned that each time an animal goes extinct, it also threatens humanity’s continued survival.
“The current extinction crisis is one of the more urgent global environmental problems and the only one [that is] truly irreversible,” study author Gerardo Ceballos of the National Autonomous University of Mexico’s Institute of Ecology told Earther. “Once a species is gone, there is no way to bring it back. Our paper indicates that is vastly speeding up.”
Modifications to chromosomes in “engram” neurons control the encoding and retrieval of memories.
When the brain forms a memory of a new experience, neurons called engram cells encode the details of the memory and are later reactivated whenever we recall it. A new MIT study reveals that this process is controlled by large-scale remodeling of cells’ chromatin.
This remodeling, which allows specific genes involved in storing memories to become more active, takes place in multiple stages spread out over several days. Changes to the density and arrangement of chromatin, a highly compressed structure consisting of DNA and proteins called histones, can control how active specific genes are within a given cell.
Analysis revealed that variants in the HMGCR gene region, which represent proxies for statin treatment, were associated with overall cancer risk, suggesting that statins could lower overall cancer risk.
Cholesterol-lowering drugs called statins may reduce cancer risk in humans through a pathway unrelated to cholesterol, says a study published today in eLife.
Statins reduce levels of LDL-cholesterol, the so-called ‘bad’ cholesterol, by inhibiting an enzyme called HMG-CoA-reductase (HMGCR). Clinical trials have previously demonstrated convincing evidence that statins reduce the risk of heart attacks and other cardiovascular diseases. But evidence for the potential effect of statins to reduce the risk of cancer is less clear.
“Previous laboratory studies have suggested that lipids including cholesterol play a role in the development of cancer, and that statins inhibit cancer development,” explains lead author Paul Carter, Cardiology Academic Clinical Fellow at the Department of Health and Primary Care, University of Cambridge, UK. “However, no trials have been designed to assess the role of statins for cancer prevention in clinical practice. We decided to assess the potential effect of statin therapy on cancer risk using evidence from human genetics.”