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Monday, February 4, 2019

Early Aerobic Exercise Speeds Concussion Recovery

Young athletes recovered more quickly from sport-related concussion with an early, progressive, aerobic exercise regimen in a 103-patient randomized trial.
Adolescents who performed individualized, sub-symptom threshold aerobic exercise soon after concussion recovered in a median of 13 days, compared with 17 days for adolescents in a stretching program (P=0.009), reported John Leddy, MD, of the University of Buffalo, and co-authors in JAMA Pediatrics.
“This research provides the strongest evidence yet that a prescribed, individualized aerobic exercise program that keeps the heart rate below the point where symptoms worsen is the best way to treat concussion in adolescents,” Leddy said in a statement.
Because exercise can exacerbate concussion symptoms, the standard of care for sport-related concussion has been prescribed rest until symptoms resolve. This protocol emerged from 2001 guidelines which recommend rest until athletes were “completely asymptomatic,” noted Sara Chrisman, MD, MPH, of the Seattle Children’s Research Institute, in an accompanying editorial.
“However, no definition was provided for the term asymptomatic, and no time limits were placed on rest, and as a result, rest often continued for weeks or months,” Chrisman wrote. With new iterations of guidelines, “clinicians began to use extreme physical and cognitive rest as a treatment for concussion, dubbing this approach ‘cocoon therapy’ — no sports, no physical activity, no screens, and no social interaction.”
In 2009 to 2010, studies showed benefits of rehabilitative exercise in individuals with refractory concussion symptoms, and in 2016, recommendations changed to limit rest to no more than 24 to 48 hours. “These new guidelines opened up the possibility of intervening with exercise at an earlier post-concussion point, with a goal of preventing persistent concussive symptoms,” Chrisman noted.
This led to the current study of exercise to treat acute concussion, the first randomized clinical trial of its kind, according to Leddy and colleagues. In it, they studied 103 teenage athletes (mean age of about 15) who presented within 10 days of sport-related concussion at four concussion clinics in North America. They excluded individuals with depression, anxiety, attention-deficit/hyperactivity disorder (ADHD), and other factors that could delay concussion recovery.
The researchers assessed exercise tolerance with the Buffalo Concussion Treadmill Test, then randomly assigned participants to a progressive sub-symptom threshold aerobic exercise regimen (n=52) or a progressive placebo-like stretching program that would not elevate heart rate substantially (n=51). No interventions started before 48 hours from injury.
Participants were seen an average of 4.9 days post-concussion in the aerobic exercise group and 4.8 days in the stretching group. There were no differences in age, sex, previous concussions, initial symptom severity score, or initial exercise treadmill test and physical examination results between the groups.
In the aerobic exercise intervention, participants exercised at home with a heart rate monitor, 5 days a week for 20 minutes per session, at 80% of the HR achieved at symptom exacerbation on the treadmill test. They were told to rest apart from the prescribed exercise and were seen in person weekly to retake the treadmill test and set a new HR threshold.
Participants rated symptoms daily with the post-concussion symptom scale. The trial stopped when participants reached symptomatic recovery, defined as a score of 7 or fewer points on the symptom scale for 3 days and confirmed by a normal physical exam and the ability to exercise to exhaustion on the treadmill test without exacerbating symptoms.
Delayed recovery — recovery lasting ≥30 days — had a numerically higher but statistically nonsignificant incidence in the stretching (n=7) than the aerobic group (n=2). Total symptom scores decreased more rapidly in the exercise group, but this did not reach significance either.
“The results of this study should give clinicians confidence that moderate levels of physical activity, including prescribed sub-symptom threshold aerobic exercise, after the first 48 hours following sport-related concussion can safely and significantly speed recovery,” Leddy and co-authors concluded.
Research about exercise and concussion has been in transition, and “this is a landmark study that may shift the standard of care toward the use of rehabilitative exercise to decrease the duration of concussion symptoms,” Chrisman observed.
But it has important limitations, she pointed out. The study did not include athletes with depression, anxiety, or ADHD, even though these diagnoses are prevalent in youth seen for concussion. “In addition, the authors did not measure physical activity objectively, and thus it is impossible to estimate the dose of exercise required to elicit a treatment outcome,” she continued.
The study also did not observe participants during exercise, noted Leddy and his group. It did not address mechanisms responsible for the effect of exercise after concussion. Results may not apply to groups like younger children or people with concussions from car crashes, they added, and larger samples from multiple centers using an intent-to-treat design are needed.
This study was supported by the NIH. The researchers reported no conflicts of interest.
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Gwyneth Paltrow’s Snake Oil

Actress Gwyneth Paltrow is well known for her lifestyle brand, goop, that promotes controversial health and wellness concepts and sells products related to her unusual ideas.
Once again, it’s that time of year when Ms. Paltrow’s fancy turns to promoting detox diets. As posted on her website:
“2018 was a year of incredible, nourishing, healing food here at goop, but in the spirit of balance, we also indulged in some less-than-clean favorites (like lasagna, schnitzel, waffles, and so many fun cocktails). Again, striving for balance, we’re recalibrating this month with our annual January detox program.”
As in the past, Gwyneth depends on her detox guru, Dr. Alejandro Junger, who is well known in the “detox market” for his Clean program. Dr. Junger’s basic elimination diet rules include “no caffeine, alcohol, dairy, gluten, corn, nightshades (tomatoes, eggplants, peppers, potatoes), soy, refined sugar, shellfish, white rice, or eggs. The no’s are replaced with nutrient-dense leafy greens, cruciferous veggies, hearty grains, seeds, and lean proteins.”
“The 5 Day Detox Plan” starts each day with warm water with lemon. For breakfast, there is grain-free granola, smoothies with coconut and chia, or a cauliflower/black bean scramble. “Portable” lunches include soup (borscht, beans and greens) or salad (leftover salmon patty salad, kale caesar, or detox bun). The dinner menu features salmon Patties with turmeric cauliflower rice, beans and greens soup, roasted chicken with cauliflower, tom yum soup, and blackened trout with roasted sweet potatoes and arugula salad. Snacks range from apple with almond butter, date balls, brown rice cakes and “toum with crudités” (a Lebanese garlic sauce — which the website claims: “This condiment — along with the process of making it — is not for the faint of heart”).
The plan comes with a shopping list, a menu plan with helpful hints such as making some of the items on the Sunday before you start and buying your trout the day before or the day of to ensure its freshness, as well as the recipes for each meal.
Oh, and if that seems like it would take too much time to prepare, don’t worry, Gwyneth’s got you covered. Meet “The Working Girl Detox!”
“Many of us could use a good detox but simply don’t have the time for the full Monty. Or even the half Monty. Enter the Working Girl Detox — an abbreviated, streamlined version of our annual five-day goop detox, this three-day reset can really make a difference in how you feel, with much less work. Breakfast is a simple but inventive DIY instant oatmeal, lunch is a packable vegan puréed soup, and dinner happens all in a single sheet pan, in around thirty minutes. Every recipe is healthy, delicious, and so easy, even the busiest person can pull it off. For at least three days.”
What are Detox Diets and Cleanses and Does Anyone Need Them?
Whether it’s called a detox diet or a cleanse, it doesn’t really matter. Neither has a clear-cut definition but both have similar goals — to rid/cleanse the body of supposedly harmful substances (usually referred to as “toxins”).
According to MedlinePlus from the U.S. National Library of Medicine, “Toxins are substances created by plants and animals that are poisonous to humans. Toxins also include some medicines that are helpful in small doses, but poisonous in large amounts. Toxins also include metals, such as lead, and certain chemicals in the environment.” However, in the context of commercial detox diets, the meaning of the term “toxin” is often vague or obscure.
In 2009, a group of early career scientists called The Voices of Young Science, created “The Detox Dossier.” They went to the manufacturers of 15 representative detox products and asked what toxin their product targeted and what evidence they had to support that claim. They came to the following conclusion:
“No one we contacted was able to provide any evidence for their claims or give a comprehensive definition of what they meant by ‘detox’. We concluded that ‘detox’ as used in product marketing is a myth. Many of the claims about how the body works were wrong and some were even dangerous.”
Weight loss is often a secondary goal of detoxes or cleanses. All use a restrictive diet, often in conjunction with a variety of supplements (including herbs, vitamins, seasonings, and so on). For example, The Master Cleanse, also called the Lemonade Diet, is a liquid-only diet consisting of water, lemon juice, maple syrup, and cayenne pepper taken for 10 days. It is essentially a starvation diet. Unfortunately, most of the weight loss in a detox diet is water, and the weight returns just as quickly as it left as soon as a normal diet is resumed.
Detox diets claim that they can help chronic conditions that occur when the body becomes victim to a buildup of “toxins.” As Dr. Junger puts it: “When our systems are overtaxed, they begin to break down in a multitude of ways. Allergies, headaches, depression, irritable bowel syndrome, fatigue, weight gain, and insomnia are just a few of the symptoms that can result. The majority of these common ailments are the direct result of toxin build-up in our systems that has accumulated during the course of our daily lives.” Dr. Junger’s book Clean currently is number 7 in Amazon sales rankings for alternative medicine books.
“But the science behind the detox theory is deeply flawed,” says Peter Pressman, MD, an internal medicine specialist at Cedars-Sinai Medical Center in Los Angeles. “The body already has multiple systems in place — including the liver, kidneys, and gastrointestinal tract — that do a perfectly good job of eliminating toxins from the body within hours of consumption.”
Detox dieters often report a variety of benefits, but most of these improvements may be due to changes in the diet unrelated to any change in “toxin levels.” For instance, a decrease in headaches could be related to elimination of caffeine or alcohol in the diet. Decreased bloating just from eating less. Clearer skin may be related to better hydration.
Is there any scientific evidence to support the dubious claims of detox proponents? Almost none. There is a 2015 study by Kim et al. “Eighty-four premenopausal women were randomly divided into 3 groups: a control group without diet restriction (Normal-C), a pair-fed placebo diet group (Positive-C), and a lemon detox diet group (Lemon-D). The intervention period was 11 days total: 7 days with the lemon detox juice or the placebo juice, and then 4 days with transitioning food.” Women in the Lemon-D and Positive-C groups had significantly greater changes in body weight, BMI, and percentage of body fat than the control group. In addition, serum insulin levels, leptin, and adiponectin levels decreased in the Lemon-D and Positive-C groups. But there was no significant difference between the Lemon-D and Positive-C groups in any of these measurements- suggesting that the main contributing factor was caloric restriction.
A 2015 review by Klein and Kiat, in the Journal of Human Nutrition and Dietetics, pointed out a study on UltraClear (Metagenics Inc), the only commercial detox product to have been evaluated clinically. UltraClear is a medical food supplement that purports to detoxify the liver. A study, by MacIntosh and Ball, gave 25 naturopathy students UltraClear for 7 days. There was no placebo control group. They reported a “statistically significant (47%) reduction in the Metabolic Screening Questionnaire [MSQ] scores.” The MSQ is a series of questions used to gauge the severity of a variety of health conditions — from acne, mood swings, and even dark circles under the eyes.
Klein reported that there were (at the time of his review) no current rigorous scientific studies that investigated the effectiveness of commercial detox diets for losing weight.
Are detox diets safe? Possibly, for otherwise healthy people, if used for only a brief period of time. However, the diets can be stressful because of feelings of hunger and deprivation. But prolonged use of these diets can lead to electrolyte imbalances and protein and vitamin deficiencies. Occasionally, there have been reports of potential risks such as kidney damage from green smoothies (Makkapati, 2018) or liver failure from detox teas (Kesavarapu, 2017).
Despite the lack of evidence that detox diets have any real health benefits, they remain incredibly popular due to celebrity endorsements and intensive marketing of the diets and related products. Have any of your patients discussed these diets with you? What has been your reaction or advice?
Michele R. Berman, MD, and Mark S. Boguski, MD, PhD, are a wife and husband team of physicians who have trained and taught at some of the top medical schools in the country including Harvard, Johns Hopkins, and Washington University in St. Louis. Their mission is both a journalistic and educational one: to report on common diseases affecting uncommon people and summarize the evidence-based medicine behind the headlines.
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Circassia prepares for potential US launch of nitric oxide product

UK biotech Circassia has said that its partner AIT Therapeutics has held a meeting with the FDA that paves the way for premarket approval of its nitric oxide product for newborn babies with respiratory failure, AirNOvent.
AirNOvent is a portable system delivering precise quantities of nitric oxide, using smart filters to remove unwanted NO2.
Nitric oxide is approved in the US as part of a regimen to treat life threatening hypoxic respiratory failure associated with persistent pulmonary hypertension of the newborn.
There is only one inhaled product available – Mallincrodt’s InoMax, which is estimated by Circassia to generate around $400m annually, based on full year 2017 figures.
Following a successful pre-submission meeting, China-based AIT expects to apply for premarket approval in Q2 this year, and will seek a label extension for the product’s use in a related indication.
Circassia then hopes to launch the product in the US, after paying AIT $7.35 million up front.
Further payments of up to $25.2 million are due if certain targets are met under the terms of a deal to acquire US and Chinese rights to the product late last month.
The deal covered all potential indications in the hospital setting for the drug at up to 80 parts per million, which included the neonatal indication.
Circassia will raise the money to fund the milestone payments by issuing shares.
The UK biotech will also pay tiered royalties on gross profits from future sales of the product.
Circassia is trying to bounce back after abandoning development of four allergy drugs, that it had hoped would produce revenues of more than $2 billion.
But the drugs failed to produce results in two phase 3 trials in cat and house dust mite allergy and Circassia abandoned development two years ago.
Since then it has struck a commercial collaboration with AstraZeneca to promote the latter’s drug for chronic obstructive pulmonary disease, and has rights to the follow-on product Duaklir.
Later this year Circassia expects to take full control of Tudorza in the US under the terms of the agreement.
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Teva’s migraine drug Ajovy looks set for EU approval

Teva’s migraine drug Ajovy (fremanezumab) has moved closer to the EU market after the influential CHMP regulatory committee gave it the green light.
The decision paves the way for European approval, which usually follows a positive opinion from the CHMP within a few months.
Ajovy is one of a group of calcitonin gene-related peptide (CGRP) class drugs that are coming to market.
Novartis was first to market with its CGRP drug Aimovig (erenumab) in Europe, which was approved in July last year.
Teva’s Ajovy has been recommended for prophylaxis of migraine in adults who have at least four migraine days per month.
The injected biologic drug can be given either quarterly or monthly, as opposed to Aimovig, which must be given every four weeks.
Ajovy is important to Teva because the company is in need of new revenues after its $40.5 billion acquisition of Allergan’s generics business left it saddled with debt.
The positive CHMP opinion is based on the review of a filing that included efficacy and safety data from the HALO clinical development programme.
The programme evaluated Ajovy in two pivotal phase III clinical trials that enrolled patients with disabling migraine and studied fremanezumab as a prophylaxis of migraine in adults.
In these trials, patients treated with fremanezumab had a significantly greater reduction in migraine days compared to placebo.
Adverse drug reactions observed with Ajovy were mostly mild to moderate, short-lasting skin reactions around the injection area: pain, hardening, redness, itching and rash at the injection site.
Richard Daniell, executive vice president, European Commercial at Teva, said: “We are very pleased to report a positive opinion by the CHMP.”
“This is another important milestone for us and the migraine community as a whole. We hope to expand the availability of Ajovy to the EU so that eligible patients can potentially benefit from the flexibility Ajovy offers through quarterly and monthly dosing options.”
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Keto in a pill? Mellon anti-aging JV dedicated to inducing ketosis

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Jim Mellon’s crew at Juvenescence has found its latest venture idea in a popular diet making its rounds in biotech circles.

Once again teaming up with the Buck Institute for Research on Aging, Juvenescence has launched BHB Therapeutics to explore preventative medicines that have potential to protect against age-related disease by inducing a state of ketosis, where the body burns fat instead of carbs, spurring the production of anti-inflammatory ketone bodies.
In particular, the biotech startup will focus on the ketone body beta-hydroxybutyrate, or — you guessed it — BHB. Eric Verdin, the Buck president and CEO whose research inspired another Juvenescence spinout, has discovered that BHB helps the body respond to stress.

A ketogenic diet — which has been heralded for its effects in weight loss, hunger suppression as well as concentration — and the consequent longterm exposure to ketone bodies can also extend healthy lifespan in model systems, Verdin and collaborator John Newman found.
The duo has generated “hard scientific data” in mice that show ketosis can be cardio-protective, CEO Greg Bailey told Endpoints News. Obviously, they have a long way to go.
“The reason we think that cardio-protection may translate to humans is because if given sugar or ketones, many people’s hearts prefer ketones, whereas the brain is the opposite,” he said. “If given the option between sugar or ketones, the brain will take sugar. Unfortunately, individuals when they hit 50 (plus or minus a couple years) they become insulin resistant — and then the sugar can go seriously high in a variety of organs and that leads to a variety of different pathologies.”
The company is looking to begin “aggressive safety studies” in the near-term, Bailey added. Should the compounds be found safe, he plans to take alternative routes rather than the conventional regulatory pathway — which he believes can lead to quicker human testing.

Just days ago, Juvenescence unveiled the first $46 million tranche of a promised $100 million raise that’s designed to bankroll longevity projects with the collective goal of extending the human lifespan to 150 years. So far, it’s ticked off stem cell tech and organ regeneration among the fields it’s established itself through joint ventures with AI groups — Insilico and Netramark — and controlling interests in AgeX and LyGenesis.
The goal, founder and chairman Mellon said back then, is to have 18 projects underway by the end of the year.
Look for two or three of them to be announced over the next few weeks, Bailey said, noting that there should also be three or four letters of intent going out shortly.
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Diamandis’ right hand man wants to reverse aging via $100M longevity fund

Inspired by British billionaire Jim Mellon, chairman of anti-aging upstart biotech venture Juvenescence, Sergey Young unveiled a $100 million fund on Monday to catalyze the development of a comprehensive solution to counteract the damaging consequences of aging.
“I’ve never looked like my age…and with my name, I think it was predetermined that I was going to work in the space (of aging),” Young told Endpoints News. The 47-year-old considers himself a product of Peter Diamandis — the man behind the non-profit XPRIZE and venture capital fund BOLD Capital Partners — and is in charge of all things longevity at both organizations.

Like Mellon, who penned Juvenescence: Investing in the Age of Longevity prior to the launch of the company Juvenescence, Young is in the embryonic stage of writing his own book designed to decode the science of aging for the masses. Meanwhile, his $100 million Longevity Vision Fund will back organizations who are working on technology to reverse the aging process and prolong healthy human life.
“Adding 20 to 30 healthy years on a person’s life is likely to be the largest market opportunity on earth. The convergence of Genome Sequencing, AI & Cellular Medicine will enable breakthroughs that will make 100 years old the new 60. I’m proud through our BOLD Capital partnership to support Sergey Young and the Longevity Vision Fund,” Peter Diamandis said in a statement.
Young did not disclose the deals his fund is currently exploring but laid out the areas he is interested in pursuing.

“We are currently working on 6 deals…and are looking at all the usual suspects in terms of themes” he said. These areas include early detection of serious diseases using ultrasound technology; early diagnostics for heart, cancer and neurodegenerative diseases; stem-cell and microbiome-based therapeutics; and big data as well as AI-based applications.
Unsurprisingly, Young is in dialogue with Alex Zhavoronkov’s AI shop at Insilico Medicine. Zhavoronkov has deep connections in the R&D space — last year he raised funds at the behest of Shanghai high-flyer WuXi AppTec, Singapore’s Temasek, Peter Diamandis and Juvenescence.
“We do plan to participate in the next round of funding to become a shareholder of Insilico,” Young said. It is a mutual appreciation society here at the Longevity Leaders Congress in London, where Zhavoronkov is heard introducing Young as a visionary fund manager to a conference attendee. Young, Zhavoronkov, Mellon and a host of others high-profile C-suite regulars involved in aging R&D have flocked to a hotel near the renowned St Paul’s Cathedral to discuss recent developments in anti-aging. In the first keynote panel of the day, vice president of Juvenescence-backed AgeX Aubrey de Grey ambitiously claims that that longevity space will eventually “dwarf the dotcom boom.”

But more funding is necessary, Zhavoronkov told Endpoints News at the conference. Other than Google’s anti-aging biotech Calico that has seen a large influx of funds, the field of anti-aging is ripe for investment, he said.
For long-time investor and venture capitalist Young, who has insight into the aging R&D effort within the US and to a lesser extent in the UK, China and India’s sizable populations pose compelling prospects for deals for his fund.
“In the next decade, advancements will allow us to be a lot more predictive and preventative in the most damaging diseases,” he said. “I’m thinking AI-enabled medicine will empower doctors…technological advances to improve sleeping and meditation will emerge — and these are an essential part of a healthy, long life, along with a plant-based diet.”
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Aimmune to present AR101 and peanut allergy data at AAAAI

Aimmune Therapeutics announced that it will present data on AR101, oral immunotherapy, and peanut allergy at the 2019 American Academy of Asthma, Allergy and Immunology Annual Meeting, taking place February 22-25 in San Francisco. “We are excited by the new data being presented at AAAAI, which deepen our understanding of AR101 and how it may benefit children, teens and families struggling with the uncertainty of life with peanut allergy,” said Daniel Adelman, M.D., Chief Medical Officer of Aimmune. “Our goal with AR101 oral immunotherapy is to train the immune system so that allergic reactions with accidental exposures are less frequent and severe. Taken together, the new data presented at AAAAI help to elucidate how AR101 delivers on our therapeutic thesis, providing continued immunomodulation throughout the course of the treatment period studied, as evidenced by greatly reduced adverse events due to accidental exposures to peanuts. These data provide further evidence of the effects demonstrated in the exit food challenge in PALISADE, with a 94% reduction of epinephrine use in the AR101-treated patients at the 600-mg exit food challenge dose. Also, we are seeing increases in efficacy over time, as nearly two thirds of the AR101 patients who tolerated less than the highest dose at the PALISADE exit were able to tolerate more peanut protein in the follow-on study challenge, and half the patients overall were able to tolerate 2,000 mg as the single highest tolerated dose.”
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