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Thursday, August 20, 2020

Facebook announces fastMRI—an AI enhancement for MRI machines

Facebook has announced on its blog that its AI research team has been working with radiologists at NYU Langone Health to create an AI system that can speed up MRI machines. A paper written by the team describing the new technology is to be published in the American Journal of Roentgenology. https://81bdf5f3ee0ba9d86ac09e0688671cfa.safeframe.googlesyndication.com/safeframe/1-0-37/html/container.html

MRI scans are excellent tools for doctors, allowing a noninvasive look inside a human patient’s body. But they take a long time—usually an hour or more. This length of time can be difficult for young patients or those who are in pain and are asked to keep still for the entire scan. Failure to do so can result in loss of resolution. MRI scans are also notoriously disliked by patients because they involve lying in an enclosed tube and loud noise. In this new effort, the researchers have used artificial intelligence to dramatically speed up the process—Facebook claims by as much as four times.

The new system, called fastMRI, works in much the same way as other AI systems. The system is first trained on hundreds or thousands of MRI scans of human body parts to teach it what an MRI film looks like. Then, it is used with the scanning software in the MRI machine to build an MRI film: in essence, filling in information that the system predicts will eventually be in the image.

The research team has tested the system by having trained radiologists compare knee films from traditional MRI scans with those that were sped up using the fastMRI technology. Facebook claims that the radiologists could not distinguish the regular images from those that had been created using the new technology, leading them to describe the output as interchangeable. They also claim that the new technology allowed for creating MRI films in 75% less time, in about 15 minutes.

The researchers have been working on fastMRI for two years, and are now ready for other groups to test it in preparation for commercial use. And because it works with existing MRI machines and is open source, they expect radiologists to be using it within two years.




More information: Michael P. Recht et al. Using Deep Learning to Accelerate Knee MRI at 3T: Results of an Interchangeability Study, American Journal of Roentgenology (2020). DOI: 10.2214/AJR.20.23313




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Low-carb, high-fat diet effect on older populations

A new study, published in Nutrition and Metabolism, from researchers with the University of Alabama at Birmingham’s Nutrition Obesity Research Center observed improvements in body composition, fat distribution and metabolic health in response to an eight-week, very low-carbohydrate diet.

Older adults with obesity are at particularly high risk of developing cardiometabolic disease such as Type 2 diabetes and cardiovascular disease. Rather than total fat mass, deposition of fat in certain areas, such as the abdominal cavity and skeletal muscle, may confer this greatest risk of disease development.

The study’s lead author is Amy Goss, Ph.D., RDN, an assistant professor with UAB’s Department of Nutrition Sciences. Goss says her team aimed to determine if a very low-carbohydrate, or VLCD, high-fat diet would deplete these fat depots and preserve lean mass without intentional caloric restriction in older adults with obesity, thereby improving outcomes related to cardiometabolic disease, such as insulin sensitivity and the lipid profile.

“After the eight-week intervention, despite the recommendation to consume a weight-maintaining diet, the group consuming the very low-carbohydrate diet lost more weight and total fat mass than the control diet group,” Goss said.

Egg consumption was an important part of the VLCD prescription. Goss and her team provided eggs to the participants in this diet group and asked them to consume at least three per day.

“While eggs were a part of this study, we can’t conclude that our findings are a result of daily egg consumption; but I think what we can conclude is that whole eggs can be incorporated into the diet in a healthful way without adversely impacting blood cholesterol in older adults,” she said.

The primary difference in fat lost between the two groups was from the abdominal cavity and the skeletal muscle depots.

“We also found significant improvements in the overall lipid profile that would reflect decreased risk of cardiovascular disease,” Goss said. “Further, insulin sensitivity improved in response to the very low-carbohydrate diet reflecting reduced risk of Type 2 diabetes. Overall, we observed improvements in body composition, fat distribution and metabolic health in response to an eight-week, very low-carbohydrate diet.”

VLCD effect on diabetes

Goss says VLCDs are a therapeutic option for many conditions, including Type 2 diabetes, obesity and non-alcoholic fatty liver disease.

“This study extends previous research to show that it can be a safe, therapeutic option for older adults in their 70s experiencing obesity,” she said. “This is the first study to demonstrate depletion of ‘metabolically harmful’ fat depots while preserving skeletal muscle during weight loss in response to a VLCD in older adults.”

Goss adds that there is quite a bit of evidence about the benefits of a very low-carbohydrate diet in younger populations, and this study was one of the first to test this dietary approach to improve outcomes related to obesity in adults older than age 65—a population at particularly high risk of other diseases and in need of therapeutic interventions to improve health while preserving skeletal muscle mass to prevent or delay functional decline with age.

A good or bad egg?

“Historically, eggs have received a bad rap beginning with the nutrition guidelines on egg consumption set forth by the American Heart Association in 1968,” Goss said. “It was recommended that no more than three whole eggs be consumed each week.”

Goss adds that the concern stemmed from the cholesterol and saturated fat content of the egg yolk. Since then, these recommendations have loosened because more recent research demonstrated the negligible impact of dietary cholesterol on blood cholesterol. And just this month, the Dietary Guideline Advisory Committee issued recommendations to increase the consumption of eggs across the lifespan, including pregnant and lactating women, and also as a first food for infants and toddlers.

“This historical first for the Dietary Guidelines Committee recognized eggs as an important, nutrient-rich food source, as eggs are a rich source of protein, choline, B12, selenium, vitamin D and a long list of other nutrients vital to growth and development as well as maintenance of muscle mass,” Goss said.




More information: Amy M Goss et al, Effects of weight loss during a very low carbohydrate diet on specific adipose tissue depots and insulin sensitivity in older adults with obesity: a randomized clinical trial, Nutrition & Metabolism (2020). DOI: 10.1186/s12986-020-00481-9


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Quidel finds no issues in investigation into faulty results with coronavirus test August 20, 2020

Quidel (OTC:QDEL +2.5%) has completed its investigation of a report from a testing location in Vermont of false positives generated by its Sofia SARS Antigen FIA (fluorescent immunoassay) run on the Sofia 2 instrument.

The company says it found no testing site- or product-related problems with either.

It looked into matter after receiving a complaint that certain patients tested positive with its test who later tested negative using a molecular test (PCR).


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Coherus Neulasta biosimilar loses preferred status at Express Scripts

Coherus BioSciences (CHRS -2.6%) slips on below-average volume in apparent reaction to the exclusion of Udencya (pegfilgrastim-cbqv), a biosimilar to Amgen’s (AMGN -0.8%) Neulasta, from Express Scripts’ 2021 preferred formulary that goes into effect January 1.

The pharmacy benefit manager’s preferred Neulasta biosimilars for next year are Mylan’s (MYL -0.9%) Fulphila (pegfilgrastim-jmdb) and Novartis’ (NVS +1.9%) Ziextenzo (pegfilgrastim-sndz).


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Drugmakers slash prices to win China’s bulk-buy contracts

August 20, 2020

Drugmakers have slashed prices by up to 95% to win state contracts in China’s largest bidding round of its drug procurement programme, state media said on Thursday.
Beijing has implemented a national scheme where global pharmaceutical companies and Chinese generic drugmakers vie to sell their products in bulk at public hospitals.
In the latest bidding round for contracts worth hundreds of billions yuan in total, drugmakers cut prices by 53% on average, state media Xinhua reported, citing preliminary results.
It involves 55 types of medicines, more than the previous two rounds.
Drugs open for bidding covered some products that contributed more than $1 billion each to foreign drugmakers’ sales in 2019 but face challenges from generic versions offered by local drugmakers.
They included AstraZeneca Plc’s (AZN.L) heart disease treatment Brilinta, and blood-thinner Eliquis, jointly developed by Pfizer Inc (PFE.N) and Bristol Myers Squibb Co (BMY.N). Contracts for the two treatments were won by Chinese companies, according to preliminary results published by procurement authorities.
Foreign companies generally quoted higher prices in Thursday’s bidding and barely secured any contracts, said ICBC International Research analyst Zhang Jialin.
More expensive brand-name drugs still had opportunities in the market not covered by the national procurement scheme, thanks to their higher profile among patients and doctors compared with cheaper generic drugs, Zhang said.
Thursday’s bidding also showed China’s generic drugs market starting to concentrate around a few big players, Zhang added.
Units of Shanghai Pharmaceuticals Holding (601607.SS) won bids for six products, the parent company said in a filing.
For smaller firms, the bulk-buy scheme might risk driving them close to losses, said Wang Yue, a professor at Peking University’s School of Health Humanities.
“Many companies actually have no power to bargain with the government,” he said. “When the market changes, like when labour and logistics costs rise, the (low drug) prices are hard to sustain.”
For most products in Thursday’s bidding, if a single company won the bid, it could provide up to half of the total procurement volume in the first year. If there were at least four winners, 70-80% of the volume could be shared, procurement authorities said in official guidance last month.

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Bayer resolves U.S. Essure claims for $1.6B

August 20, 2020

Bayer (OTCPK:BAYRY -1.6%) has agreed to settle ~90% of the 39K claims in the U.S. over alleged injuries related to its Essure permanent implanted birth control device.
Under the terms of the settlements, it will pay a total of $1.60B (€1.35B) without admitting liability or wrongdoing.
Talks to resolve the remaining ~10% of claims are in process.
The company stopped selling the product in 2018 but did not recall the units in the field.

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FDA warns Xeris over Gvoke ad; shares down

Xeris Pharmaceuticals (XERS -13.3%) is down on more than double normal volume in apparent reaction to its receipt of an FDA Warning Letter concerning its promotion of Gvoke (glucagon), approved in the U.S. a year ago for the treatment of severe low blood sugar in diabetics at least two years old.

The agency states that its television advertisement makes “false and misleading” claims and representations about the risks associated with the product, which constitutes misbranding, requesting that it immediately stop violating federal law.

The company has until Friday, August 28, to submit its written response to the letter.


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