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Thursday, July 4, 2019

Quorn protein builds muscle better than milk protein

A study from the University of Exeter has found that fungus-derived mycoprotein, the protein-rich food source that is unique to Quorn products, stimulates post-exercise muscle building to a greater extent than milk protein.
The study evaluated the digestion of protein, which allows amino acids (the building blocks of protein) to increase in the bloodstream and then become available for muscle protein building in 20 healthy, trained young men at rest and following a bout of strenuous resistance exercise.
The young men performed the exercise and were then given either milk protein or mycoprotein.
Their muscle building rates were then measured using stable isotope labelled “tracers” in the hours following protein consumption.
Animal proteins like milk are an excellent source for muscle growth, so they provide a useful comparison for testing other protein sources.
The results showed that while those who ingested milk6 protein increased their muscle building rates by up to 60%, those who had mycoprotein increased their muscle growth rates (MGRs) by more than double this — showing that mycoprotein, the main ingredient in all Quorn products, is a more effective source of protein to promote muscle growth.
“These results are very encouraging when we consider the desire of some individuals to choose non-animal derived sources of protein to support muscle mass maintenance or adaptations with training,” said Dr Benjamin Wall, Associate Professor of Nutritional Physiology, University of Exeter.
“Our data show that mycoprotein can stimulate muscles to grow faster in the hours following exercise compared with a typical animal comparator protein (milk protein) — we look forward to seeing whether these mechanistic findings translate to longer term training studies in various populations.”
Tim Finnigan, Chief Scientific Adviser for Quorn Foods, said “We’re excited to see this data being presented by the University of Exeter at ECSS. In a world where many people are trying to cut back on their meat consumption, either for environmental or health reasons, we’re happy to be able to offer an alternative protein that can provide exceptional nutrition and muscle growth, all while being meat-free.”
Recent research has suggested that current recommendations for protein intake are too low — some scientists have calculated that minimum protein requirements could have been underestimated by as much as 30-50% in some populations.1
The British Nutrition Foundation already recommends mycoprotein as a good source of dietary protein, both for everyday life and for sport and exercise.
However, in the UK roughly a third of total protein consumption comes from meat products — and increasing meat intake may have serious consequences for public health and for the environment.
A pivot to “alternative” sources of protein therefore may be advisable — and mycoprotein is well placed to fill the gap.
Story Source:
Materials provided by University of ExeterNote: Content may be edited for style and length.

DOJ asks Congress to permanently classify fentanyl-like drugs

A temporary order classifying fentanyl-like drugs as controlled substances should be enacted into law, the U.S. Department of Justice is telling Congress.
The order—which was enacted in 2018 on an emergency basis and expires in February 2020—tightened controls on fentanyl-like drugs, which had skirted federal law because their chemical makeup is slightly different than the opioid fentanyl, which is about 100 times stronger than morphine, CBS News reported. Fentanyl-like drugs can be even stronger.
“From a policy and regulatory perspective, fentanyl-like substances need to be permanently scheduled as a class,” said Katie Crytzer, the acting deputy assistant attorney general in the Office of Legal Policy at the Department of Justice, CBS Newsreported. The  is an “urgent and necessary first step,” she told reporters Monday.
Of the more than 70,000  in the U.S. in 2017, nearly 48,000 were caused by opioids, and about 29,000 by fentanyl or fentanyl-like , according to U.S. Centers for Disease Control and Prevention data, said John Martin, assistant administrator of the Drug Enforcement Administration, CBS News reported.

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More information: CBS News Article

Soccer headgear may not reduce sport-related concussion

In season-long tests, soccer headgear didn’t reduce the overall number or severity of concussions experienced by high school players, U.S. researchers say.
Some of the five headgear models used in the trial, however, may have been better at reducing impact forces that lead to concussions, particularly among female players, the study authors report in the British Journal of Sports Medicine.
“Female soccer is late to the party in terms of recognizing the number of injuries. So much focus has been on football that we haven’t recognized that females are more at risk for knee injuries and concussions,” said Timothy McGuine of the University of Wisconsin School of Medicine and Public Health in Madison, who led the study.
High school female soccer players have about double the rate of concussions as males, he said, and based on participation numbers, that’s about the same rate reported among football players.
“Athletic trainers at schools have been saying this for years, but we couldn’t get people to take it seriously,” he told Reuters Health in a phone interview. “Now parents tell us their daughters have experienced two or three concussions during a season and missed a month of school.”
Few studies have looked at the efficacy of protective headgear during soccer practices and matches, especially among high school athletes, McGuine noted. So, he and his colleagues studied 2,766 high school players, two thirds of them girls, over two academic years.
The researchers assigned about half the teams to wear headgear during an entire season while the rest did not. Individuals were allowed to choose which headgear model to wear from among five models that met American Society for Testing Materials International standards and were approved for use by the National Federation of State High School Associations.
Licensed athletic trainers at the schools recorded information about concussions and other injuries.

Overall, there were 130 sport-related concussions during the study, with 108 of these in girls. Twelve participants, including 11 girls, were medically disqualified from soccer for the rest of the season. The others spent about five days in a return-to-play protocol and missed about 13 days from soccer during a season.
But there was no difference in rates of sport-related concussions among those who wore headgear and those who didn’t. The number of days lost due to sport-related concussion also didn’t differ between the groups.
“Most safety devices haven’t been studied beyond a company’s lab settings,” McGuine said. “We weren’t able to formally study the brands, but we did see a discrepancy in the rates between different headgear.”
About the same number of players wore a model called the Storelli ExoShield, for example, as wore one called the Ultra Forcefield Sweatband, but half as many concussions were among players wearing the Storelli model.
Future studies will need more in-depth analysis of different types of headgear, which can become expensive to test, McGuine said. Researchers and national soccer associations should work together to discuss rule changes and technique changes to help high school athletes reduce these injuries and concussions in the first place, he added, both for high school teams and local club teams.
“Many schools are required to have athletic trainers who can recognize concussions, but there’s no mandate for clubs to do that, and we’re finding two-thirds of girls don’t have access to the safety or care that they need,” he said. “As a parent, ask your coaches if they’re aware of this and if they do baseline testing.”
As studies continue, parents should consider the risks of sport-related concussion versus the benefits of physical activity and team participation, said Doug Martini of Oregon Health and Science University in Portland, who wasn’t involved in the study

In his own research looking at long-term issues after high school concussions, he didn’t consistently find long-lasting effects, Martini notes. As heading techniques change and concussion protocols improve, the benefits of sport will likely outweigh the risks, he added.
SOURCE: bit.ly/2J9Qdp0 British Journal of Sports Medicine, online May 14, 2019.

Opioid drug defendants ask Oklahoma judge to end case

The defendants in Oklahoma’s trial against drugmakers are asking a judge to rule in their favour, arguing the state has failed to prove they’re responsible for the opioid epidemic.
Attorneys for consumer products giant Johnson & Johnson and Janssen Pharmaceuticals filed a motion for judgment Wednesday after the state rested its case.
Oklahoma called its last witness on Tuesday, a former sales representative for Johnson & Johnson. The drugmakers’ case is expected to take about four more weeks.
Oklahoma Attorney General Mike Hunter has called Johnson & Johnson and its subsidiaries a “kingpin” responsible for the state’s ongoing opioid epidemic.
Johnson & Johnson attorney John Sparks says the state is seeking damages from the company without any evidence that it caused the problem.

Using CRISPR to eliminate HIV

Antiretroviral therapy (ART) is the standard of care for HIV. These drugs can prevent HIV from replicating but they can’t clear the virus from the body altogether. Now, in a step closer to a possible cure for the infection, a team of scientists has removed HIV from mice using the CRISPR-Cas9 gene-editing technology and long-acting ART.
HIV integrates its genetic material into the genomes of the host’s cells, which currently available ART can’t target. In a study in Nature Communications, scientists at Temple University and the University of Nebraska Medical Center said the combination of CRISPR and a newly developed ART successfully eliminated HIV DNA from about 30% of infected mice.
Excision BioTherapeutics, a biotech focused on using CRISPR to treat viral infections, has licensed the gene-editing technology from Temple University, with a plan to advance the platform into human clinical trials. Senior author Kamel Khalili, Ph.D., professor and chair of neuroscience at Temple’s Lewis Katz School of Medicine at Temple University, is the founder and principal scientific advisor of Philadelphia-based Excision.
Khalili and his Temple colleagues previously used CRISPR to cut off large fragments of HIV DNA from infected immune cells. However, similar to ART, gene editing alone didn’t completely eliminate HIV. So they figured that a CRISPR-based system could be more effective when the HIV viral load is already controlled at low levels.
For the study, Khalili’s team used a new therapeutic called long-acting slow effective release antiviral therapy (LASER ART), which was co-developed by Howard Gendelman and Benson Edagwa at UNMC. LASER ART packages HIV drugs into nanoparticles that target tissues where latent HIV resides. It dissolves and releases ART slowly, with a higher proportion of the drug entering the circulation, the researchers said. That also helps lessen off-target toxicity.
To test their idea, the team built a mouse model that was engineered to resemble human HIV infection. In two separate experiments, infected mice received either the combination therapy, solo CRISPR or solo LASER ART, or they were left untreated. In the combo group, LASER ART was given used to suppress HIV growth, and then CRISPR was used to eliminate the remaining HIV DNA.
Eight weeks following the last administration of LASER ART and five weeks after the single CRISPR treatment, the animals were observed for evidence of viral rebound. Notably, about one-third of the rodents that got the combo therapy showed no sign of HIV, according to the team. DNA and RNA analysis of the spleen, bone marrow, gut, brain, liver, kidney and lung tissues of the rodents showed no traces of the virus’ genomic material. What’s more, the researchers also found no off-target effects that could be attributed to CRISPR.

The use of CRISPR in HIV stirred up much controversy after Chinese scientist He Jiankui claimed to have used the technology to edit human embryos, resulting in the birth of babies with a mutated form of the CCR5 gene that rendered them resistant to HIV. However, in the current research, CRISPR was not used for germline editing as it was in the China study.
Khalili, Gendelman and colleagues believe that their new approach marks the first time that replication-competent HIV DNA has been eliminated from the genomes of living animals.
“The big message of this work is that it takes both CRISPR-Cas9 and virus suppression through a method such as LASER ART, administered together, to produce a cure for HIV infection,” Khalili said in a statement. “We now have a clear path to move ahead to trials in non-human primates and possibly clinical trials in human patients within the year.”

Purdue hires Ducharme as CSO to aid expansion beyond opioids


Purdue Pharma CSO Julie Ducharme. (Mundipharma)

Novartis struggles for payer coverage for $2.1M gene therapy Zolgensma: analysts

Only about one-third of the top 30 U.S. insurance companies have made their decisions about how to cover Novartis’ new $2.1 million gene therapy to treat spinal muscular atrophy (SMA), Zolgensma, but analysts at one influential Wall Street firm are already worried.
Ronny Gal and his colleagues at Bernstein collected early coverage decisions on Zolgensma from 11 payers and found them to be “surprisingly restricted,” the firm said in a Tuesday note to clients.
“The restriction reflects unexpected and material payer resistance to the Zolgensma price point” and suggests that even if Novartis produces more data from ongoing clinical trials of the product, “payers will only grudgingly expand coverage and penetration into the broader population,” they wrote.
A spokesperson for Novartis said via email that the company does not believe Bernstein’s analysis represents “an accurate picture of the reimbursement situation or decisions that are occurring on the ground.” “[M]ultiple patients across different SMA types, weights and ages” have been treated and covered, the spokesman added, and the company will provide additional details when it releases its second-quarter earnings results on July 18.
Zolgensma kicked up a pricing controversy long before the FDA approved it, after one Novartis executive suggested the gene therapy would be cost-effective at a price of $4 million to $5 million. Then the Institute for Clinical and Economic Review (ICER) released a report saying Zolgensma would not be cost-effective at any price higher than $1.5 million.
But after Zolgensma was approved and priced, Novartis won over the cost watchdogs by saying it would work with payers to develop outcomes-based installment payments spread over five years. That would bring the per-year cost to $425,000, half what it would cost to treat a patient with the leading chronic drug therapy, Biogen’s Spinraza, for 10 years, Novartis said at the time. ICER subsequently said Zolgensma is worth up to $2.1 million.

Nevertheless, the initial coverage moves are more restrictive than Zolgensma’s label is. For example, Horizon Blue Cross of New Jersey is not covering the gene therapy for patients previously treated with Spinraza, Bernstein found, and nine of the companies won’t allow concurrent treatment with Spinraza. Health Net is requiring any patient who’d used Spinraza to prove their disease progressed while on treatment before it will cover Zolgensma.
Four of the insurers Bernstein surveyed are refusing to treat presymptomatic SMA patients—a major red flag, Gal and colleagues wrote.
Gene therapy, after all, is meant to be a cure. Treating children before they develop symptoms offers the potential for a healthy life many can’t achieve with chronic drug therapy. And even though clinical trials ahead of Zolgensma’s approval focused on symptomatic patients, the FDA approval allows its use in those who haven’t developed symptoms yet.
Therefore, Bernstein analysts said, “by making coverage choices that may be legally defensible but deny Zolgensma to patients who could clearly benefit, the payers are sending a clear signal that they are very unhappy with the price of Zolgensma.”

Payer resistance may be bad news for Novartis, but it’s a boon for Biogen, at least in the short term. Bernstein’s analysis of Zolgensma coverage decisions prompted the firm to boost its estimates for Spinraza, which has a sticker price of $750,000 for the first year and $375,000 per year after that. Bernstein now projects Spinraza sales of nearly $1.4 billion by 2024, not $1 billion as it previously estimated.
Other Wall Street firms are even more optimistic about Spinraza’s ability to compete with Novartis’ pricey Zolgensma. The consensus estimate places sales of Spinraza at $2.2 billion this year, with receipts growing slightly each year until 2023, when it peaks at $2.3 billion in sales.
So can Novartis overcome early resistance from payers? Absolutely, Bernstein said. The company is running additional trials, which could deliver data to persuade insurance companies to ease up on their coverage restrictions. Novartis is also working with patient advocacy groups to “apply pressure to ICER,” the analysts wrote, in the hopes that the cost watchdog will increase its estimate of a fair Zolgensma price.
For Novartis, “it is a long path ahead,” Bernstein concluded.
But the broader message from payers about gene therapy is clear, the analysts said: If there is competition on the market, expect pushback on price.