7 Ways to Tell if You're Pushing it Too Hard in Your Workouts
With hardcore trainers telling you to "Push harder!" all...the...time, do you ever wonder how hard is too hard? Well, you should.
If you take it too far, too often or for too long, here's what you might see:
-Regression in performance and/or gains. That's right, you can actually lose that lean muscle you've worked so hard to build, endurance you've been building, and even confidence in yourself.
-You can get injured. Over-exhaustion leads to poor form which can lead to injuries. No fun.
-Bigger issues like Rhabdomyolysis, where the muscle breaks down and releases nasty toxins in your body that can make you sick or even lead to death.
How can you tell if you're pushing it too hard? Good question. Here are those 7 ways you can tell.
1) Your Heart Rate Monitor tells you. For those using a wearable that tracks your heart rate, note that you should not be in the red (over 90%) on the regular for more than a few minutes.
2) You vomit.
3) It’s still hard to breathe when you stop the activity.
4) You don’t have energy after the workout.
5) Your form goes bad.
6) You feel any sort of sharp pain, a.k.a. bad pain.
7) You are sore instantly.
So, in the spirit of challenging your body to change your body, yes, push it! But be smart and avoid pushing so hard that you set yourself back.
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For Alternative Health Practitioners, Laying the Groundwork for Referrals Requires a Slow, Steady Process
Greer, SC, July 9th – Can acupuncturists, naturopaths, chiropractors, and other alternative health practitioners receive a steady stream of referrals from traditional medical doctors? The answer is yes, says Dr. Ron Grisanti, founding director of Functional Medicine University (www.functionalmedicineuniversity.com), but it takes patience and a systematic approach.
“We teach our Functional Medicine practitioners to introduce themselves to as many local family practice doctors and specialists as they can, but they need to introduce themselves in a certain way,” explains Dr. Grisanti. “Step by step they build familiarity, credibility and trust with the other doctors, and only after a very long process of properly laying the groundwork can they expect referrals to flow. However, once those medical referrals start coming, the benefit of that period of preparation lasts a very long time.”
Health care professionals who enroll in Functional Medicine University’s postgraduate educational program receive realistic marketing guidance and tools along with clinical instruction in the Functional Medicine approach to diagnosing and treating bodily dysfunctions ranging from asthma and arthritis to ulcers and yeast infections. Continuing education credits are available for chiropractors, naturopaths, acupuncturists, osteopaths, nurse practitioners, dieticians, pharmacists and dentists, as well as M.D. physicians.
The next training session at Functional Medicine University gets underway in July, 2019. For complete information, alternative health professionals who already hold professional licenses should visit www.functionalmedicineuniversity.com.
About Functional Medicine University
Founded in 2006 by Dr. Ron Grisanti, D.C., Functional Medicine University is the oldest online Functional Medicine certification training school, serving healthcare professionals from 81 countries and all 50 US states. Functional Medicine emphasizes scientific diagnosis of an individual’s unique biochemical relationships, then encouraging the body to rebalance itself naturally instead of through surgery or drugs. Founder/director Dr. Grisanti is a board certified chiropractic orthopedist with a master's degree in nutritional science from the University of Bridgeport. He also holds a diplomate degree with the American Clinical Board of Nutrition.
STAY ALERT COFFEE LOVERS, SOMETHING BIG IS BREWING WITHIN SINGLE-SERVE COFFEE
WEST COAST STARTUP SOLVES THE SINGLE-SERVE COFFEE CRISIS
TO DELIVER QUALITY WITHOUT COMPROMISE
The Award-Winning Steeped Coffee full immersion brew method means no machines, no waste, guilt-free packaging, and amazing taste
[Santa Cruz, CA, JULY 9, 2019] – Step aside, coffee pods. Take a rest, instant coffee. There’s finally a single-serve option available in the world of high-end coffee, and it’s quickly becoming a game changer.
Santa Cruz-based startup Steeped, Inc., one of the most promising and innovative companies in the industry, has launched its revolutionary Steeped Coffee brewing method to serious coffee drinkers across the nation. Brewed similar to tea, Steeped Coffee’s nitro sealed Steeped Bags, along with their guilt-free packaging made using renewable and compostable materials, achieve the unthinkable: freshly ground specialty coffee in a single-serving. That’s why it earned the “Best New Product” award for their innovative packaging at the recent Specialty Coffee Expo. And, it’s barista-approved!
Steeped Coffee launched when serial entrepreneur and coffee lover Josh Wilbur decided to combine the convenience of a single-serving brew method with the premium quality of ethically sourced coffee. Wilbur wanted to redeem the environmental dilemma created by wasteful coffee pods. Happy to do the math, Wilbur points out over 10 billion unrecyclable pods accumulate in landfills each year – enough to wrap around the earth more than 110 times if placed side-by-side. Moreover, each type of pod depends on expensive and often moldy brewing machines, which are also unrecyclable.
It took Wilbur seven years to innovate the proprietary Steeped Coffee system that delivers fresh roasted, pre-portioned, precision ground, micro batched coffee in customized Full Immersion Filters. “Premium coffee roasters have shied away from offering their specialty beans in single-serve packaging because it’s been nearly impossible to keep ground coffee fresh, which quickly ruins the taste,” said Wilbur. “With our Nitro Sealed bags, oxygen is replaced with nitrogen, so the coffee stays fresh as if it was ground moments ago.”
“Steeped Packs are the easiest way to make a delicious cup of coffee,” Wilbur Says. “You shouldn't need to perform chemistry before you’ve made your coffee.” Simply steep each Steeped Bag in hot water for about five minutes to allow the coffee to develop its distinctive body and flavor. There is no machine, no noise, no cleanup, no destructive waste.
As for flavor? Even the most discerning coffee connoisseurs in the industry are singing the praises of Steeped Coffee. Barista Magazine is a believer: “Like a tea bag—but for coffee? This new product from Steeped Coffee might just be one of our fave new ways to brew coffee on the road.”
“Finding Steeped has changed my coffee drinking life,” raved one reviewer on Producthunt.com. “It's my favorite new brewing method and I can't believe more people haven't heard of this yet. It is going to be huge.”
Entrepreneur’s Handbook concurs: “You’re likely going to see the Steeped Coffee methodology in hospitals, offices, hotels — places where single-serve coffee reigns — and perhaps on your next flight.
Features of Steeped Coffee include:
100% Specialty Coffee: quality coffee ethically sourced directly from farmers
Nitro Sealed: removes oxygen, stopping the clock on freshly ground beans
Ultrasonic Edges: no glue, staples, or wasted materials for max steeping
Full Immersion Filter: non-GMO filters that regulate ideal water-in and maximum flavor-out
Guilt-Free Packaging: made using plant-based renewable and compostable materials
Micro Batching: roasted locally in small batches
Precision Ground: consistent water-cooled grinding to the micron
Steeped, Inc., based in Santa Cruz, California, is a B-Corp (Benefit Corporation) focused on every detail from farm-to-cup and beyond, to bring people the most convenient, quality, ethically sourced, and sustainably packaged products available. Steeped Coffee provides a single-serve method that combines convenience and quality all within Guilt-Free Packaging. The proprietary Steeped Brewing Method delivers 100% freshly roasted, precision ground, and nitro sealed specialty coffee pre-portioned within Steeped Full Immersion Filters. Steeped Coffee is the simplest way to make a perfect cup of coffee, with no machine needed, just add water. Steeped, Inc. offers its brewing method to Licensed Partners around the globe. For more information, visit http://www.steepedcoffee.com. For business inquiries, contact sales@steepedcoffee.com.
With so many coffee gadgets, machines, and accessories flooding the market these days, this simple unplugged Steeped Coffee brewing method might be just what you're looking for to take your moment, while at home, at work, or on-the-go.
Photo: The Steeped Coffee full immersion brew method means no machines, no waste, guilt-free packaging, and amazing taste.
Many individuals are worried that sexualization in video games may increase female players' body dissatisfaction.
Contrary to expectations, new research findings in the American Psychological Association's journal Psychology of Popular Media Culture did not find that sexualization increased body dissatisfaction or aggression toward other women. Media influences from video games appear to be minimal.
"Examining the Effects of Exposure to a Sexualized Female Video Game Protagonist on Women's Body Image" is based on research by Danielle Lindner, Ph.D., assistant professor of psychology at Stetson University; Chris Ferguson, Ph.D., professor of psychology at Stetson University; Stetson University alumna Melissa Trible; and Ilana Pilato, Ph.D. candidate, at Fairleigh Dickinson University.
During the study, female players were randomly assigned to play either a more or less sexualized avatar in a "Tomb Raider" video game. Participants also reported on their self-objectification and body dissatisfaction as well as hostility and aggression toward a female character. Research results indicated that exposure to a sexualized avatar in a video game did not influence any outcomes for female participants. These results indicate that, at least for video games, exposure to sexualized females may not have a substantial impact on female players.
The journal article link includes additional information. Dr. Lindner is a body image expert and is available to discuss the research findings that published in the Psychology of Popular Media Culture. Below you will find the journal and faculty profile links.
Psychology of Popular Media Culture journal article link:
The issue of whether aggressive video games contribute to aggressive behavior in youth remains an issue of significant debate. One issue that has been raised is that some studies may inadvertently inflate effect sizes by use of questionable researcher practices and unstandardized assessments of predictors and outcomes, or lack of proper theory-driven controls.
New research findings in Springer's Journal of Youth and Adolescence did not find aggressive video games causing future aggression in youth.
"Aggressive Video Games Are Not a Risk Factor for Future Aggression in Youth: A Longitudinal Study" is based on research conducted by Dr. Ferguson and C.K. John Wang, Ph.D., professor of sport and exercise psychology at Nanyang Technological University in Singapore.
In the recently published journal article, more than 3,000 youth around the age of 11 in Singapore, with nearly 73 percent being male, were assessed for links between aggressive game play and seven aggression or prosocial outcomes two years later.
Participants were asked to rate three video games they currently played and how often they played them both on weekdays.
STONEFIELD VILLA RESORT LAUNCHES AN EXCLUSIVE FITNESS RETREAT WITH CANADIAN CELEBRITY AND FITNESS EXPERT JANA WEBB
TORONTO, ON (July10, 2019) - Stonefield Villa Resort, a premier health and wellness boutique property nestled at the base of Saint Lucia's famous Pitons has partnered with fitness expert and Reebok spokesperson, Jana Webb to launch a weeklong fitness retreat from November 17 – 24th, 2019 offered exclusively through WestJet Vacations.
Webb, an original cast member of the Real Housewives of Toronto, is the founder of JOGA World, a movement system made up of yoga combined with the biomechanics of sports training. Joga was created during a personal journey of rehabilitation following a car crash that left Webb severely injured. Her unique program enhances athletic performance, improves concentration, decreases recovery time, and ultimately, transforms an athlete's game.
The Jana Webb Fitness Retreat, is an all-inclusive package with roundtrip flights on WestJet, including luxury villa accommodations at Stonefield Villa Resort. The package will feature daily personalized workouts; a 60-minute spa treatment; customized healthy meal options at the resorts award-winning farm to table restaurant - Mango Tree; airport transfers; Sulphur Springs Volcano mud bath excursion, hiking the famous Pitons and a full day catamaran experience along the islands west coast.
Saint Lucia offers travellers an elevated wellness experience; the volcanic island is home to the healing Sulphur Springs, a restorative mineral mud bath, lush rainforests and the iconic Pitons that rise majestically out of the Caribbean Sea. Webb visited Saint Lucia in November 2018 to scout properties for her first fitness retreat aboard. After reviewing the island top wellness attractions and resorts, she selected Stonefield Villa Resort to host her high-end clientele on a week-long fitness/wellness retreat.
“To find a getaway that combines the zen of the ocean and the adventures of the rainforest is rare,” remarked Jana Webb, founder of JOGA. “Stonefield Villa Resort’s exquisite farm to table service and magical views from your own private villa will be a time in your life you will never forget. Saint Lucia will inspire you! My motto in life is work hard and play harder. Join me for the first ever, all-inclusive - Jana Webb Fitness Retreat partnered with WestJet Vacations and Stonefield Villa Resort. I guarantee a week of fun, fitness, amazing food, relaxation, adventure, laughs and friendship.”
The Jana Webb Fitness Retreat is sold exclusively through WestJet Vacations, visit http://westjet.com/stonefield to book you package today or call Toll Free: 1-888-937 - 8538.
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About Stonefield Resort
Stonefield Villa Resort is one of the most desirable destinations for the discerning Caribbean traveller. This 17-villa boutique property is nestled at the base of St. Lucia's Pitons overlooking the Caribbean Sea. Guests relax, luxuriate and rejuvenate in spacious secluded villas each with large private pools, outdoor garden showers, large verandas and extraordinary views of the Petit Piton and the Caribbean Sea. The resorts' full-service spa, gym, and yoga studio have attracted fitness and wellness groups globally offering annual retreats for exceptional rejuvenation. Consistently rated over four stars on Trip Advisor, Stonefield Resort and Spa has become a yearly award-winning vacation escape for visitors all over the world.
INTRODUCING WONDER MELON™, THE NEWEST IN
TREND-FORWARD HEALTHY BEVERAGES
KAYCO RIDES THE WATERMELON WAVE WITH HEAVY PROMOTIONAL SUPPORT IN NYC SUMMER 2019
Delicious, Organic Drink Delivers Powerful Hydration in Two Refreshing Varieties:
Spicy Watermelon Lemon Cayenne
Cool Watermelon Cucumber Basil
Bayonne, NJ, July 9, 2019 – The consumers have spoken. Watermelon, one of today’s fastest-trending fruits, has enjoyed triple-digit growth in casual and fine dining. Demand for the refreshing summer staple is on the rise even in the fall and winter months. It’s a must for any mixologist and you’ll find it on one in 10 restaurant menus.
Most of all, people just love watermelon – and they know it’s good for them.
KAYCO (www.kayco.com) is taking the beverage industry by storm with Wonder Melon™, the latest thirst-quencher for those seeking clean, uniquely flavorful new refreshment options. Wonder Melon™ is made from 100% organic cold-pressed juice with no added sugar, artificial ingredients, or artificial colorings.
This healthy game-changer comes in two exciting varieties. Watermelon Cucumber Basil is a delightfully cool concoction of real watermelon juice, lemon juice, apple juice, cucumber juice, and basil, with only 80 calories per 8.45 oz. bottle. Watermelon Lemon Cayenne wakes up the taste buds with real watermelon juice, lemon juice, apple juice, and a dash of cayenne at just 100 calories per 8.45 oz. bottle.
“Wonder Melon™ perfectly captures what consumers are looking for right now,” says Kim Cassar, Kayco’s EVP Sales & Marketing – Beyond Division. “It’s not only healthful and out of the ordinary, but also undeniably trendy and irresistibly delicious. We’re confident that Wonder Melon™ will make a huge splash this summer.”
Both varieties are non-GMO verified, certified Fair Trade, USDA organic, and certified OU kosher (parve). Packaged 6 bottles per case ($3.99/bottle MSRP), Wonder Melon™ is available in the refrigerator section at Shop-Rite, Fairway, Best Market, independent grocers and Amazon.
Promotional Blitz
Kayco is supporting the Wonder Melon™ brand in New York City with an aggressive outreach campaign at the height of cold beverage season. Look for the following promotions:
Segments on Time Warner Cable’s A Taste of New York, targeting affluent, influential, and educated New Yorkers. This spot will also be featured on A Taste of New York’s web site, YouTube channel, Facebook page, Twitter feed, Pinterest site and Instagram. Sneak Peak - https://vimeo.com/tasteofny/download/340913533/0963707776
Eye-catching Wonder Melon™ Vans will cruise the steamy summer streets with refreshing samples for thirsty Manhattanites starting July 12 and running all summer. Check Wonder Melon’s™ social media for dates and locations.
Giant Wonder Melon™ trucks will roll out the product – literally – to provide additional exposure.
In-store support including tastings and point-of-purchase materials.
Watermelon Stats
According to Menu Trends research by the Watermelon Board:
All regions across the U.S. are experiencing increased use of watermelon.
Watermelon is featured in one of 10 menus – up by 27% in the last four years.
Watermelon is one of the fastest fruit flavors in non-alcoholic beverages, with 29% four-year growth.
82% of consumers surveys said they liked the taste of watermelon.
Wonderful Watermelon Facts
Watermelon’s 92% water content is excellent for hydration. It contains a bounty of nutrients, antioxidants, vitamins, and minerals associated with the following:
Digestive health
Eye, skin, and hair health
Sun protection
Diabetes protection
Heart and blood vessel health
Weight loss
Combating asthma
Weight loss
Nerve function
Reduction of inflammation
Wonder Melon™ Recipes:
Cucumber Cooler
2 oz cucumber mint vodka
1/2 oz lemon juice
.25 oz simple syrup
2 oz Wonder Melon™ with Juice, Watermelon, Cucumber and Basil
Splash cucumber juice
Pineapple Punch
2 oz pineapple infused vodka
1.5 oz Wonder Melon™ with Juice, Watermelon, lemon, and cayenne
Splash simple syrup
.5 oz pineapple juice
.5 oz peach schnapps
Summer Refresher
2 oz. vodka
1/2 oz. Watermelon juice
1/4 oz. Simple syrup
1 oz. Lemon juice
1 oz. Wonder Melon™ with Juice, Watermelon, Cucumber and Basil
Sugar rim
Wonder Melon Rita
2 oz. Tequila
1 1/2 Wonder Melon™ with Juice, Watermelon, lemon, and cayenne
Kayco is one of the largest manufacturers and suppliers of kosher foods. Its expanded Kayco Beyond Division sources and distributes new products to the general market beyond kosher, to meet the demands of consumers looking for optional products that are healthful, convenient and/or for restricted diets and lifestyles. These brands include Dorot, Absolutely Gluten Free, Beetology, Mighty Sesame, Tuscanini Foods, Wissotzky Tea Co. and new Wonder Melon™. They are headquartered in Bayonne, NJ. (www.KAYCO.com).
Photo:Wonder Melon™ is the latest thirst-quencher for those seeking clean, uniquely flavorful new refreshment options. It’s made from 100% organic cold-pressed juice with no added sugar, artificial ingredients, or artificial colorings. Look for the official Wonder Melon™ Mobile Trucks hitting the streets of New York summer 2019.
Health Canada Approves Pomalyst®-Based Triplet Combination for Patients With Multiple Myeloma
POMALYST®, in combination with bortezomib and dexamethasone, provides a new medication option for patients living with multiple myeloma
TORONTO, July 10, 2019 /CNW/ - Celgene Inc. announced today that Health Canada has approved a POMALYST® (pomalidomide)-based triplet combination with bortezomib and dexamethasone. This is a new treatment option for patients with multiple myeloma (MM) who have received at least one prior treatment regimen that included REVLIMID® (lenalidomide).
POMALYST® is an oral medication taken daily and is indicated, in combination with bortezomib and dexamethasone, for the treatment of adult patients with MM who have received at least one prior treatment regimen that included lenalidomide.1,2
"The treatment landscape for multiple myeloma has significantly changed over the years. New treatment options like this POMALYST®-based triplet combination allow patients and their physicians to work together to find the best early-line treatment regimen," says Dr. Reece, Princess Margaret Cancer Centre. "In the pivotal clinical trial, OPTIMISMM, we saw the POMALYST®-based triplet combination improve and provide a sustained progression-free survival for multiple myeloma patients who were exposed to, and for the most part refractory to lenalidomide. This is important, as over the last few years lenalidomide has become a standard of care in front-line treatment of multiple myeloma in Canada and until OPTIMISMM, the patient population exposed or refractory to lenalidomide in front line was not well studied. The POMALYST®-based triplet combination is a positive step forward in the treatment journey for multiple myeloma patients and their loved ones."
MM is an increasingly prevalent blood cancer originating from bone marrow plasma cells.3 In Canada, the number of patients living with the disease is on the rise, with eight Canadians diagnosed each day.4
"Multiple myeloma is a complex disease which can impact each patient differently," says Martine Elias, Executive Director, Myeloma Canada. "It is encouraging to see how new treatment options, like the POMALYST®-based triplet combination, successfully treat Canadian myeloma patients."
Health Canada's approval of the POMALYST®-based triplet combination with bortezomib and dexamethasone is based on OPTIMISMM, the first prospective phase 3 trial, including 559 MM patients, to evaluate a POMALYST®-containing triplet regimen in patients.5 Patients participating in this trial were all previously treated with REVLIMID® and the majority, 70 per cent, were REVLIMID® refractory.6,7 All patients had received 1-3 prior antimyeloma regimens and demonstrated disease progression on or after the last therapy.8
Patients who received the POMALYST®-based triplet combination with bortezomib and dexamethasone in the clinical trial had a significantly longer progression-free survival (PFS) of 4.1 months more than those who received only bortezomib and dexamethasone (median PFS 11.2 months versus 7.1 months, respectively).9,10
About Multiple Myeloma
MM is a life-threatening blood cancer characterized by tumor proliferation and suppression of the immune system.11,12 It is a rare but deadly disease – around 2,900 people are diagnosed with MM in Canada and 1,450 Canadians die from the disease each year.13 The typical MM disease course includes periods of symptomatic myeloma followed by periods of remission, and eventually, the disease becomes refractory (non-responsive).14 While all MM patients may experience different symptoms during and after treatment, patients may also experience physical issues.15 These may include bone complications, anemia, infections, kidney damage, high blood calcium and other blood complications, osteonecrosis of the jaw, side effects of medication, as well as bone pain, nerve pain and neuropathy.16MM patients may also experience emotional health issues, with 40 per cent of cancer patients experiencing depression or anxiety.17
About OPTIMISMM
OPTIMISMM is the first phase 3 trial designed to compare the safety and efficacy of a POMALYST®-based triplet combination with bortezomib and dexamethasone versus only bortezomib and dexamethasone as an early line of therapy in patients with relapsed or refractory multiple myeloma (with 1-3 prior regimens of therapy) and prior REVLIMID® exposure, including REVLIMID®-refractory patients.
This multi-center, international, open-label, randomized phase 3 clinical trial included 559 patients (281 patients in the POMALYST®-based triplet combination with bortezomib and dexamethasone arm and 278 in the bortezomib and dexamethasone arm). Demographic, baseline, and prior disease characteristics were generally well balanced between the two treatment arms. All patients had prior treatment with REVLIMID®, with the majority being REVLIMID® refractory (71 per cent in the POMALYST®-based triplet combination arm versus 69 per cent in the bortezomib and dexamethasone arm) and 70 per cent versus 66 per cent, respectively, were refractory to their last treatment. Median follow-up was 16 months.
Results from OPTIMISMM showed that patients receiving the POMALYST®-based triplet combination with bortezomib and dexamethasone treatment achieved a significantly longer PFS than those in the bortezomib and dexamethasone treatment arm (11.20 months versus 7.10 months, respectively [HR 0.61, p= < 0.0001; 95 per cent CI: (0.49-0.77)]), reducing the risk of disease progression by 39 per cent in the POMALYST®-based triplet combination arm. In an exploratory sub-group analysis of patients with one prior line of therapy, median progression-free survival with the POMALYST®-based triplet combination with bortezomib and dexamethasone was 20.73 months versus 11.63 months with bortezomib and dexamethasone (HR 0.54; 95 per cent CI: 0.36, 0.82).
Patients were stratified based on age (< 75 years old versus 75 years old), number of prior anti-myeloma regiments (1 vs. > 1) and β2-microglobulin levels (<3.5 mg/L versus > 3.5 to < 5.5 mg/L versus > 5.5 mg/L). Patients were randomized 1:1 to receive the POMALYST®-based triplet combination with bortezomib and dexamethasone or bortezomib and dexamethasone. In 21-day cycles, patients received POMALYST® 4 mg on days 1-14 (POMALYST®-based triplet combination arm only); bortezomib 1.3 mg/m2 on days 1, 4, 8 and 11 for cycles 1-8 and on days 1 and 8 for cycles 9 and onwards; and dexamethasone 20 mg/day (10 mg if aged > 75 years) on the days of and after receiving bortezomib treatment.
About Celgene's Immunomodulatory Drugs
IMiD® agents are Celgene's proprietary small molecule, orally available compounds for the treatment of some blood cancers. IMiD® agents are hypothesized to have multiple mechanisms of action. They have been found to enhance T cells and (NK) cell-mediated immunity. In addition to immunomodulatory properties, IMiD® agents are hypothesized to have tumoricidal and antiangiogenic activity. Celgene's portfolio of IMiD® agents have become a foundation of multiple myeloma research, with a growing number of studies exploring these compounds as combination partners across a range of settings of the disease.
About POMALYST® (pomalidomide)
POMALYST® in combination with bortezomib and dexamethasone is indicated in the treatment of adult patients with MM who have received at least one prior treatment regimen that included lenalidomide. It belongs to a group of drugs called immunomodulatory drugs (IMiDs®).
About Celgene
Celgene is an integrated global biopharmaceutical company engaged primarily in the discovery, development and commercialization of novel therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit the company's website at www.celgene.ca.
Indications and Clinical Use:
POMALYST® in combination with dexamethasone and bortezomib is indicated in the treatment of adult patients with MM who have received at least one prior treatment regimen that included lenalidomide.
POMALYST® in combination with dexamethasone is indicated for patients with multiple myeloma for whom both bortezomib and lenalidomide have failed and who have received at least two prior treatment regimens and have demonstrated disease progression on the last regimen.
Geriatrics (> 65 years of age):
Concomitant administration of dexamethasone may increase the risk of infection, particularly pneumonia; dexamethasone dosing may need to be reduced or interrupted in case of infection. Reduce dexamethasone dose by half in patients >75 years of age.
Contraindications:
Pregnant women and women at risk of becoming pregnant
Breastfeeding women
Male patients unable to follow or comply with the required contraceptive measures
Hypersensitivity to POMALYST®, thalidomide, lenalidomide or to any ingredient in the formulation or component of the container
Controlled Distribution Program:
Available only through a controlled distribution program called RevAid®
Serious warnings and precautions:
POMALYST® should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents.
Pregnancy: Potential for human birth defects, stillbirths, and spontaneous abortions
Hematologic: Neutropenia and thrombocytopenia
Infections, including fatal cases
Venous thromboembolism: Deep vein thrombosis (DVT) and pulmonary embolism (PE)
Hepatic: Hepatotoxicity, including fatal cases
Hepatitis B virus reactivation, including fatal cases
Severe dermatologic reactions: Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS), including fatal cases
Tumour lysis syndrome, including fatal cases
Other Relevant Warnings and Precautions:
Cardiovascular disorders
Second primary malignancies
Immune reactions: Use in patients with active hepatitis A, B, or C infection; hypersensitivity reactions (angioedema, urticaria)
Interstitial lung disease
Neurologic: Possible impairment of mental and/or physical abilities; peripheral neuropathy
Use in hepatic impairment or renal impairment
Monitoring and Laboratory testing required
Combination treatment with bortezomib; consult bortezomib Product Monograph prior to initiating treatment
For More Information:
Please consult the Product Monograph at pomalystpm.ca for important information relating to adverse reactions, drug interactions and dosing information. The Product Monograph is also available by calling 1-877-923-5436.
ProMIS Neurosciences to Present Data at 2019 Alzheimer's Association International Conference
Abstracts selected for oral and poster presentation
TORONTO and CAMBRIDGE, MA, July 10, 2019 /CNW/ - ProMIS Neurosciences, Inc. (TSX: PMN) (OTCQB: ARFXF), a biotechnology company focused on the discovery and development of antibody therapeutics targeting toxic oligomers implicated in the development of neurodegenerative diseases, will give an oral presentation on its lead clinical candidate, PMN310 for Alzheimer's disease, at the annual Alzheimer's Association International Conference® (AAIC), which occurs July 14-18. A second poster presentation focuses on the behavior of misfolded TDP43 involved in the development of neurological disorders such as amyotrophic lateral sclerosis (ALS) and frontotemporal dementia.
AAIC® is the largest, most influential international meeting focused on advancing dementia science. The annual conference convenes the world's leading basic science and clinical researchers, next-generation investigators, clinicians and the care research community to share research discoveries supporting new methods of prevention, treatment and diagnosis of Alzheimer's disease.
ProMIS' Chief Development Officer Dr. Johanne Kaplan will deliver the oral presentation, "Selective Targeting of Amyloid-Beta Oligomer Species By PMN310, a Monoclonal Antibody Rationally Designed for Greater Therapeutic Potency in Alzheimer's Disease," on Thursday, July 18, 2019 from 11:45 AM – 12:00 PM in Concourse Hall 151. Dr. Kaplan's slide presentation will be available on the company's website immediately following the presentation.
ProMIS' Chief Science Officer Dr. Neil Cashman will deliver the poster (#33496), "The Pathological Interactome of Tdp-43 Includes Human Wildtype SOD1" on Wednesday, July 17, 2019 in South Hall GH.
The conference takes place at the Los Angeles Convention Center. For more information, visit www.alz.org/aaic.
About the ProMIS Pipeline ProMIS Neurosciences' lead candidate, PMN310, is a monoclonal antibody for Alzheimer's disease created with the ProMIS drug discovery and development platform, a novel, proprietary method for discovering and developing antibodies that can uniquely and precisely target toxic forms of otherwise normal proteins. PMN310 selectively targets the toxic oligomeric species of amyloid beta (Aß), a root cause of Alzheimer's disease. Preclinical studies show PMN310 demonstrates a high degree of binding to toxic oligomers without binding to non-toxic forms of amyloid beta protein and greater selectivity versus other Aß-directed antibodies. ProMIS has developed antibody candidates that demonstrate high selectivity for the toxic species of naturally occurring proteins in the brain, including other antibody candidates for Alzheimer's disease that selectively target toxic Tau, antibody candidates for Parkinson's disease that show best-in-class selectivity for toxic forms of alpha-synuclein, and antibody candidates for ALS that target the toxic form of TDP43.
About ProMIS Neurosciences ProMIS Neurosciences, Inc. is a development stage biotechnology company focused on discovering and developing antibody therapeutics selectively targeting toxic oligomers implicated in the development and progression of neurodegenerative diseases, in particular Alzheimer's disease (AD), amyotrophic lateral sclerosis (ALS) and Parkinson's disease (PD). The Company's proprietary target discovery platform is based on the use of two complementary thermodynamic, computational discovery engines - ProMIS and Collective Coordinates - to predict novel targets known as Disease Specific Epitopes on the molecular surface of misfolded proteins. Using this unique precision approach, the Company is developing novel antibody therapeutics for AD, ALS and PD. ProMIS is headquartered in Toronto, Ontario, with offices in Cambridge, Massachusetts. ProMIS is listed on the Toronto Stock Exchange under the symbol PMN, and on the OTCQB Venture Market under the symbol ARFXF.
The TSX has not reviewed and does not accept responsibility for the adequacy or accuracy of this release. This information release contains certain forward-looking information. Such information involves known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by statements herein, and therefore these statements should not be read as guarantees of future performance or results. All forward-looking statements are based on the Company's current beliefs as well as assumptions made by and information currently available to it as well as other factors. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Due to risks and uncertainties, including the risks and uncertainties identified by the Company in its public securities filings, actual events may differ materially from current expectations. The Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
SOURCE ProMIS Neurosciences Inc.
Spectrum Therapeutics partners with Canadian Mental Health Association's Not Myself Today® initiative
SMITHS FALLS, ON and TORONTO, July 10, 2019 /CNW/ - Spectrum Therapeutics ("Spectrum"), the medical division of Canopy Growth Corporation (TSX: WEED) (NYSE: CGC) (the "Company" or "Canopy Growth") is pleased to announce a partnership with the Canadian Mental Health Association ("CMHA"). The initiative, a first of its kind for a leading cannabis company and a national mental health organization, will see the CMHA in collaboration with Spectrum Therapeutics develop an educational content module related to cannabis in the workplace as part of CMHA's Not Myself Today workplace mental health program. The module, slated to launch early next year, will feature a host of physical and digital engagement tools aimed to reduce stigma in the workplace on the use of cannabinoid based medicines. In addition, it will encourage greater healthcare practitioner oversight when patients use cannabis to treat a medical condition. The content will also include video resources featuring medical cannabis subject matter experts and fact sheets that provide detailed information and direct readers to further resources.
"The stigma surrounding medical cannabis and mental illness prevents meaningful action and dialogue among those affected. One of the goals of this partnership is to break that stigma by empowering conversations about mental health informed by evidence-based educational resources," said Dr. Mark Ware, Chief Medical Officer, Canopy Growth. "For Spectrum Therapeutics, this partnership presents a powerful opportunity to improve lives by enhancing physical and mental health through access to education that sparks learning along with conversations about medical cannabis in the workplace."
Estimates suggest one in two Canadians have or will have a mental illness by age 40.[1] Fifty-three percent of Canadians consider anxiety and depression to be epidemic in the country[2] and mental illness is a leading cause of disability claims in the workplace in Canada.
Not Myself Today is an evidence-based initiative designed to help employers and employees transform mental health at work. The program is embraced by more than 500 organizations across Canada and the U.S., reaching more than 350,000 employees. By breaking down barriers and making the topic of mental health engaging and accessible to all employees, Not Myself Today improves mental health literacy, reduces stigma, and shifts workplace culture to be more supportive of every employee's mental health and well-being. For the past six years, the initiative has evolved into a highly-regarded program and counts many of Canada's largest and most respected employers across corporate, government and social sectors as its champions.
"The mental health-care system of the future is not just in clinics or hospitals—it's in settings like the workplace, where we can promote the skills, knowledge and practices that can improve mental health for the broad population instead of limiting our focus to individual patients," said Fardous Hosseiny, interim National CEO, CMHA. "With the support of partners like Spectrum Therapeutics, our Not Myself Today program will educate, reduce stigma, and foster safe and supportive cultures for the one in five Canadians who experience mental illness in a given year—and for the five in five Canadians who have mental health."
The research on cannabis use and mental illness is still in its infancy and CMHA highlights that more studies are needed to understand the relationship between mental health and cannabis use, both in terms of possible benefits and risks. CMHA and Spectrum Therapeutics strongly advise that individuals speak with a health-care practitioner for advice on any mental health treatment including medical cannabis.
Spectrum Therapeutics has identified mental health as an area with high unmet medical needs and is currently engaged in clinical research in partnership with leading academic institutions and research centres to determine the role cannabis can play in addressing mood and anxiety disorders. Today's announcement builds on Spectrum Therapeutics and Canopy Growth's legacy of furthering the public's understanding of cannabis which includes partnerships with the likes of:
Parent Action on Drugs and Canadian Students for Sensible Drug Policy to educate parents, adult caregivers and youth on how to make responsible decisions about cannabis.
The Arthritis Society to create evidence-based resources to help people with arthritis learn more about the potential of medical cannabis as a treatment.
The University of British Columbia by way of a $2.5 million donation to conduct controlled trials examining the potential utility of cannabis in addressing the opioid overdose crisis and to establish the Canopy Growth Professorship of Cannabis Science.
Mothers Against Drunk Driving (MADD) and the Canadian Drug Policy Coalition to conduct an extensive research review that formed the basis for MADD Canada's recommendations on responsible cannabis use and sober driving.
Through these partnerships and support for campaigns such as Not Myself Today, Canopy Growth and its medical division, Spectrum Therapeutics is proud to provide education for patients, their families and healthcare providers on medical cannabis and its role in mitigating some of our most common healthcare issues.
Here's to Future Growth (and promoting mental wellness).
[1] Smetanin et al. (2011). The life and economic impact of major mental illnesses in Canada: 2011-2041. Prepared for the Mental Health Commission of Canada. Toronto: RiskAnalytica.
Not Myself Today® is a registered trademark of the Canadian Mental Health Association.
About Canadian Mental Health Association Founded in 1918, the Canadian Mental Health Association (CMHA) is the most established, most extensive community mental health organization in Canada. Through a presence in more than 330 communities across every province and one territory, CMHA provides advocacy, programs and resources that help to prevent mental health problems and illnesses, support recovery and resilience, and enable all Canadians to flourish and thrive. For more information, visit cmha.ca.
About Canopy Growth Corporation Canopy Growth (TSX:WEED, NYSE:CGC) is a world-leading diversified cannabis, hemp and cannabis device company, offering distinct brands and curated cannabis varieties in dried, oil and Softgel capsule forms, as well as medical devices through Canopy Growth's subsidiary, Storz & Bickel GMbH & Co. KG. From product and process innovation to market execution, Canopy Growth is driven by a passion for leadership and a commitment to building a world-class cannabis company one product, site and country at a time. Canopy Growth has operations in over a dozen countries across five continents.
Canopy Growth's medical division, Spectrum Therapeutics is proudly dedicated to educating healthcare practitioners, conducting robust clinical research, and furthering the public's understanding of cannabis, and has devoted millions of dollars toward cutting edge, commercializable research and IP development. Spectrum Therapeutics sells a range of full-spectrum products using its colour-coded classification Spectrum system as well as single cannabinoid Dronabinol under the brand Bionorica Ethics.
Canopy Growth operates retail stores across Canada under its award-winning Tweed and Tokyo Smoke banners. Tweed is a globally recognized cannabis brand which has built a large and loyal following by focusing on quality products and meaningful customer relationships.
From our historic public listing on the Toronto Stock Exchange and New York Stock Exchange to our continued international expansion, pride in advancing shareholder value through leadership is engrained in all we do at Canopy Growth. Canopy Growth has established partnerships with leading sector names including cannabis icons Snoop Dogg and Seth Rogen, breeding legends DNA Genetics and Green House Seeds, and Fortune 500 alcohol leader Constellation Brands, to name but a few. Canopy Growth owns 12 licensed cannabis production sites with millions of square feet of production capacity, including more than one million square feet of GMP certified production space. For more information visit www.canopygrowth.com
About Spectrum Therapeutics Spectrum Therapeutics, the medical division of Canopy Growth Corporation (TSX: WEED, NYSE: CGC), is dedicated to educating healthcare practitioners, furthering the public's understanding of medical cannabis and its various applications, and cutting edge, commercializable research and IP development. Founded in Canada, Spectrum Therapeutics operates in Australia, South America, Africa and across Europe. Its products are available in a wide range of potencies and formats designed to simplify the dialogue around strength and dosage by applying a colour-coded spectrum to categorize medical cannabis according to THC and CBD levels.
Spectrum Therapeutics' offerings include whole flower cannabis, oils and new innovations such as Softgels in addition to single cannabinoid medicine Dronabinol under the brand Bionorica Ethics. Through product simplification, robust clinical research and ongoing education of healthcare professionals, Spectrum Therapeutics is committed to addressing the unmet medical needs of patients around the globe.
Notice Regarding Forward Looking Statements This news release contains "forward-looking statements" within the meaning of the United States Private Securities Litigation Reform Act of 1995 and "forward-looking information" within the meaning of applicable Canadian securities legislation. Often, but not always, forward-looking statements and information can be identified by the use of words such as "plans", "expects" or "does not expect", "is expected", "estimates", "intends", "anticipates" or "does not anticipate", or "believes", or variations of such words and phrases or state that certain actions, events or results "may", "could", "would", "might" or "will" be taken, occur or be achieved. Forward-looking statements or information involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Canopy Growth or its subsidiaries to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements or information contained in this news release. Examples of such statements include "aimed to reduce stigma in the workplace on the use of cannabis as a medicine", and "content will also include video resources featuring medical cannabis subject matter experts and fact sheets". Risks, uncertainties and other factors involved with forward-looking information could cause actual events, results, performance, prospects and opportunities to differ materially from those expressed or implied by such forward-looking information, including content development and such risks contained in the Company's annual information form dated June 24, 2019 and filed with Canadian securities regulators available on the Company's issuer profile on SEDAR at www.sedar.com. Although the Company believes that the assumptions and factors used in preparing the forward-looking information or forward-looking statements in this news release are reasonable, undue reliance should not be placed on such information and no assurance can be given that such events will occur in the disclosed time frames or at all. The forward-looking information and forward-looking statements included in this news release are made as of the date of this news release and the Company does not undertake an obligation to publicly update such forward-looking information or forward-looking information to reflect new information, subsequent events or otherwise unless required by applicable securities laws.
SOURCE Spectrum Therapeutics
Numbering You Won’t Stop the Opioid Crisis
by: Jane M. Orient, M.D.
People are dying all over the country from opioid overdoses. There’s a movement to have the antidote naloxoneavailable in all ambulances and even over the counter. This temporarily reverses the fatal effect of opioids, which stop the patient’s breathing. First responders themselves may need a dose because of contact with a tiny amount of fentanyl, an extremely potent narcotic, while attending a patient.
No, the fentanyl does not come from the patient’s bottle of legal prescription drugs.
Rep. Bill Foster (D-Ill.) introduced a proposal that he claims would “go a long way to fight the practice of doctor shopping for more prescription pain pills amid a deadly opioid crisis.” Doctor shopping “involves visiting multiple doctors.” Hardly new, this proposal, now passed by the House of Representatives as an amendment to a $99.4 billion Health and Human Services appropriations bill, lifts the ban on funding a Unique Patient Identifier (UPI).
The UPI is part of the Health Insurance Portability and Accountability Act (HIPAA) of 1996. You don’t have one yet because former congressman Ron Paul, M.D., (R-Tex,) sponsored a prohibition on funding it as part of a 1999 appropriations bill. Rep. Foster’s amendment repeals Dr. Paul’s prohibition.
So how is this 1996 idea supposed to work? And why would it be better than the Prescription Drug Monitoring Programs (PDMPs) now in effect in nearly every state? Every prescription for a controlled substance must be reported to the PDMP, and the doctor must check it before writing a prescription, to be sure the patient is not lying about having prescriptions from other doctors. This costly program that creates time-consuming hassles for doctors has not prevented opioid deaths.
PDMPs are ineffective because doctor shopping is not the cause of the problem. Only 2.5 percent of misused prescription pain medicine was obtained by doctor shopping. And this small percentage apparently increased after PDMPs. More than 97% of misused medications are obtained from a single physician—or from an illicit source. The spike in opioid deaths after 2013 was caused by illicit fentanyl, as Dr. John Lilly concludes from painstaking analysis of official data.
If Rep. Foster’s amendment is not removed, you might have to have a UPI to get legitimate medical care—“no card, no care”—but the drug cartel won’t mind. You can shop drug dealers as much as you like. There is a flood of fentanyl, mostly from Mexico or China, coming across our borders. Rep. Foster is apparently unaware of the armed lookouts protecting the smuggling routes in the Tucson sector. And once here, the drugs go to distributors—such as illegal aliens protected in sanctuary cities.
So, what about the other touted benefits of the UPI? “Specifically, assigning a unique number to a patient would give doctors a way to immediately identify a patient’s medical history,” said Rep. Mike Kelly (R-Pa.). He says it “would lower the cost of medical mix-ups due to misidentification.” His elderly father was nearly given the wrong medication.
To prevent medical errors, you need alert nurses and doctors—and the UPI is not going to fix the hazards of the electronic health record. The EHR, touted as the solution that will bring efficient, quality care, has created its own type of errors.
There is no guarantee that a UPI will improve access to the record, and critical information will still be buried in voluminous, repetitious data of dubious reliability, some of which may have been cut-and-pasted from another patient’s record. There may be critical gaps as patients withhold information they don’t want in a federal database. The new problem that brings the patient to the hospital won’t be in the old record—but may be the result of an old misdiagnosis that should be corrected instead of copied.
Patients need to be able to shop for doctors, especially if the one they have has not solved their problems. Some of them desperately need opioids, which are increasingly difficult to obtain. They do not need a UPI, and neither does their doctor.
The UPI is ideally suited for government tracking and control of all citizens. People like J. Edgar Hoover or Lois Lerner might find it very useful. But it would be the end of privacy, and the foundation for a national health data system.
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Jane M. Orient, M.D. obtained her undergraduate degrees in chemistry and mathematics from the University of Arizona in Tucson, and her M.D. from Columbia University College of Physicians and Surgeons in 1974. She completed an internal medicine residency at Parkland Memorial Hospital and University of Arizona Affiliated Hospitals and then became an Instructor at the University of Arizona College of Medicine and a staff physician at the Tucson Veterans Administration Hospital. She has been in solo private practice since 1981 and has served as Executive Director of the Association of American Physicians and Surgeons (AAPS) since 1989. She is currently president of Doctors for Disaster Preparedness. She is the author of YOUR Doctor Is Not In: Healthy Skepticism about National Healthcare, and the second through fifth editions of Sapira's Art and Science of Bedside Diagnosis published by Wolters Kluwer. She authored books for schoolchildren, Professor Klugimkopf’s Old-Fashioned English Grammar and Professor Klugimkopf’s Spelling Method,published by Robinson Books, and coauthored two novels published as Kindle books, Neomorts and Moonshine. More than 100 of her papers have been published in the scientific and popular literature on a variety of subjects including risk assessment, natural and technological hazards and nonhazards, and medical economics and ethics. She is the editor of AAPS News, the Doctors for Disaster Preparedness Newsletter, and Civil Defense Perspectives, and is the managing editor of the Journal of American Physicians and Surgeons.
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