Janssen Announces Health Canada Approval of DARZALEX®* Combination Regimen for Newly Diagnosed, Transplant-Eligible Patients with Multiple Myeloma
Data show DARZALEX® in combination with bortezomib, thalidomide and dexamethasone (VTd) before and after autologous stem cell transplant improved response rates and progression-free survival compared to VTd alone
TORONTO, Dec 22, 2020 /CNW/ - The Janssen Pharmaceutical Companies of Johnson & Johnson announce that Health Canada has approved DARZALEX® (daratumumab) in combination with bortezomib, thalidomide and dexamethasone (VTd) for the treatment of patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant (ASCT).1 This represents the first Canadian approval of a biologic for newly diagnosed patients who are eligible for a stem cell transplant and it is the fifth approval for DARZALEX®.
The approval is based on results from the Phase 3 CASSIOPEIA (MMY3006) study that demonstrated the addition of DARZALEX® to VTd before and after ASCT resulted in deeper responses, as indicated by the higher stringent complete response (sCR) rate, and improved progression-free survival (PFS) compared to VTd alone.2
"This important Phase 3 clinical study is robust in terms of design, number of participating patients and efficacy results," said Dr. Richard LeBlanc, hematologist and Myeloma Canada Chair on multiple myeloma at Université de Montréal. "This study evaluated the impact of adding daratumumab before and after autologous stem cell transplantation in first line treatment and showed that the addition of daratumumab significantly reduces the risk of progression from multiple myeloma and death."
Data from the study were first presented at the 2019 American Society of Clinical Oncology Annual Meeting and simultaneously published in The Lancet.10
Results showed that the primary endpoint of sCR rate post-transplant was significantly higher in the DARZALEX®-VTd arm compared to VTd alone (29 per cent vs. 20 per cent; p-value=0.0010).3 The addition of DARZALEX® to VTd at a median follow-up of 18.8 months resulted in a 53 per cent reduction in the risk of disease progression or death compared to VTd alone (Hazard Ratio [HR] = 0.47; 95 per cent CI, 0.33–0.67; P<0.0001).4
"The DARZALEX clinical development program has led to many important firsts, but more importantly, it has generated key insights and understanding into the biology and treatment of multiple myeloma," said Craig Tendler, M.D., Vice President, Late Development and Global Medical Affairs, Oncology, Janssen Research & Development, LLC. "This milestone marks the first approval of a biologic in Canada for newly diagnosed, transplant-eligible patients and it is the fifth Canadian approval for DARZALEX®. Yet our work is far from over, as we are committed to discovering and developing innovative treatments like DARZALEX® for the benefit of patients facing a multiple myeloma diagnosis."
About the CASSIOPEIA Study This randomized, open-label, multicenter, Phase 3 study is sponsored by the French Intergroupe Francophone du Myelome (IFM) in collaboration with the Dutch-Belgian Cooperative Trial Group for Hematology Oncology (HOVON) and Janssen Research & Development, LLC.5
The study included 1,085 newly diagnosed patients with previously untreated, symptomatic multiple myeloma who were eligible for high-dose chemotherapy and stem cell transplant (median age is 58).6 In the first part of the study, patients were randomized to receive induction treatment with VTd alone or in combination with DARZALEX®, high-dose therapy and ASCT, and consolidation therapy with VTd alone or in combination with DARZALEX®.7 The primary endpoint in this part of the study is the proportion of patients who achieve a sCR at the end of consolidation therapy.8
The most frequently reported treatment emergent adverse events (≥20 per cent) in the DVTd arm were: infusion-related reactions, peripheral sensory neuropathy, constipation, asthenia, upper respiratory tract infections, nausea, peripheral edema, neutropenia, pyrexia, paraesthesia, and thrombocytopenia. Serious adverse events with a 2 per cent higher incidence in the DVTd arm compared to the VTd arm included neutropenia (DVTd 3.9 per cent vs. VTd 1.5 per cent) and pneumonia (DVTd 3.5 per cent vs. VTd 1.7 per cent).9
In the second part of the study, which is ongoing, patients who achieved a partial response or better in part one underwent a second randomization to receive maintenance treatment with DARZALEX® 16 mg/kg every eight weeks for up to two years or be observed with no further treatment. The primary endpoint in the second part of the study is PFS. 10
About DARZALEX® DARZALEX® is the first CD38-directed monoclonal antibody approved to treat multiple myeloma. In 2020, the subcutaneous formulation, DARZALEX® SC, was approved by Health Canada to treat patients with multiple myeloma.11
DARZALEX® binds to CD38, a surface protein highly expressed across multiple myeloma cells.12 DARZALEX® induces tumor cell death through cell lysis via multiple immune-mediated mechanisms of action, including complement-dependent cytotoxicity (CDC), antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP).13 DARZALEX® has also demonstrated immunomodulatory effects such as increasing CD4+ and CD8+ T-cells counts, which may contribute to clinical response.14
In August 2012, Janssen Biotech, Inc. and Genmab A/S entered a worldwide agreement, which granted Janssen an exclusive license to develop, manufacture and commercialize DARZALEX®. Janssen Inc. commercializes DARZALEX® and DARZALEX® SC in Canada. For full Prescribing Information and more information about DARZALEX® and DARZALEX®SC, please visit www.janssen.com/canada.
About Multiple Myeloma Multiple myeloma is an incurable blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow.15 When damaged, these plasma cells rapidly spread and replace normal cells with tumors in the bone marrow. In 2020, it is estimated that 3,400 Canadians will be diagnosed with multiple myeloma and there will be 1,600 deaths associated with the disease.16 While some patients with multiple myeloma have no symptoms in the early stages, patients are diagnosed due to symptoms that can include bone disease or pain, anemia, calcium elevation, and kidney problems.17
About the Janssen Pharmaceutical Companies of Johnson & Johnson At Janssen, we're creating a future where disease is a thing of the past. We're the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.
Learn more at www.janssen.com/canada. Follow us at @JanssenCanada. Janssen Inc. and Janssen Research & Development, LLC are part of the Janssen Pharmaceutical Companies of Johnson & Johnson.
*All trademark rights used under license.
**Dr. LeBlanc was not compensated for any media work. He has been compensated as a consultant.
Cautions Concerning Forward-Looking Statements This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding DARZALEX®. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Inc., any of the other Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 29, 2019, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in the company's most recently filed Quarterly Report on Form 10-Q, and the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
References:
1 DARZALEX® Product Monograph, Janssen Inc., Nov 17, 2020 2 DARZALEX® Product Monograph, Janssen Inc., Nov. 17, 2020 3 DARZALEX® Product Monograph, Janssen Inc., Nov. 17, 2020 4 DARZALEX® Product Monograph, Janssen Inc., Nov. 17, 2020 5 Moreau, P et al. Bortezomib, thalidomide, and dexamethasone with or without daratumumab before and after autologous stem-cell transplantation for newly diagnosed multiple myeloma (CASSIOPEIA): a randomised, open-label, phase 3 study. The Lancet. 2019; 394: 29–38. 6 DARZALEX® Product Monograph, Janssen Inc., Nov. 17, 2020 7 DARZALEX® Product Monograph, Janssen Inc., Nov. 17, 2020 8 DARZALEX® Product Monograph, Janssen Inc., Nov. 17, 2020 9 DARZALEX® Product Monograph, Janssen Inc., Nov. 17, 2020 10 Moreau, P et al. Bortezomib, thalidomide, and dexamethasone with or without daratumumab before and after autologous stem-cell transplantation for newly diagnosed multiple myeloma (CASSIOPEIA): a randomised, open-label, phase 3 study. The Lancet. 2019; 394: 29–38. 11 Janssen Research & Development, LLC. A Study to Evaluate Subcutaneous Daratumumab in Combination With Standard Multiple Myeloma Treatment Regimens. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000 [cited July 5, 2019]. Available at: https://clinicaltrials.gov/ct2/show/NCT03412565. Identifier: NCT03412565. 12 DARZALEX® Product Monograph, Janssen Inc., Nov. 17, 2020 13 DARZALEX® Product Monograph, Janssen Inc., Nov. 17, 2020 14 DARZALEX® Product Monograph, Janssen Inc., Nov. 17, 2020 15 Kumar, SK et al. Risk of progression and survival in multiple myeloma relapsing after therapy with IMiDs and bortezomib: a multicenter international myeloma working group study. Leukemia. 2012 Jan; 26(1):149-57. 16 Canadian Cancer Society. "Signs and Symptoms of Multiple Myeloma." Available at: https://www.cancer.ca/en/cancer-information/cancer-type/multiple-myeloma/statistics/?region=on. Accessed November 2020. 17 Canadian Cancer Society. "Signs and Symptoms of Multiple Myeloma." Available at: http://www.cancer.ca/en/cancer-information/cancer-type/multiple-myeloma/signs-and-symptoms/?region=on. Accessed November 2020.
SOURCE Janssen Inc.
The Fertility Partners Acquires Two Additional Clinics
The fastest growing partnership of Canada's leading fertility clinics expands across Central and Western Canada.
TORONTO, Dec. 22, 2020 /CNW/ -The Fertility Partners ("TFP"), Canada's leading platforms of fertility practices across Canada, announced today an expansion of their network with the acquisition of two additional clinics: Aurora Reproductive Care and Kelowna Regional Fertility Centre (KRFC). The Fertility Partners launched in 2019 and has quickly become the business partner of choice with Clinicians and Researchers making it the fastest-growing network offering fertility treatments and associated services in the country. The Fertility Partners network covers all aspects of reproductive medicine, a wide range of laboratory diagnostics and is supported by world-renowned Physicians, Embryologists and Andrologists. The combined group of companies has grown to 8 clinics with full IVF laboratories, 20 locations in 5 provinces since July, 2020.
The Fertility Partners is a world-class business partner of choice for leading fertility centres across North America. (CNW Group/The Fertility Partners). The Fertility Partners shares a common vision with its clinics, providing access to medical, strategic and operational best practices, investing in new technologies, promoting research and development and offering synergistic back-office support. The TFP partner model empowers physicians and their teams to focus on doing what they do best- provide the highest quality patient focused fertility care.
"As we continue to grow our market coverage and geographical footprint, it is our goal to foster global best clinical outcomes, an international reputation for excellence, and exceptional patient and employee experiences, says TFP's Founder, CEO & Executive Chairman Dr. Andrew Meikle. Adding, "We are very excited to partner with Kelowna Regional Fertility Centre and Aurora Reproductive Care. These acquisitions allow The Fertility Partners to expand our care to include the British Columbia Interior/South Okanagan and Saskatchewan which is an important part of our mission to provide fertility care across all of Canada."
Aurora Reproductive Care is the only comprehensive healthcare facility in the province of Saskatchewan and provides state of the art care with a leading diagnostic clinic servicing the local market. "Our laboratory is designed by industry leaders and is a critical part of our medical success and the success of our clinic," says co-founder Dr. Adrian Gamelin. "Since our launch, our focus has been to provide high quality, compassionate reproductive health care to the people of Saskatchewan. This partnership allows us to continuously improve and provide more services to our community." says co-founder Dr. Allison Case.
"As the business partner of choice in Canada, it is important for us to find partner clinics that share in our mission and dedication to patient focused care." said Dr. Meikle. "We were thrilled to find this kind of partner in Aurora and KRFC."
Kelowna Regional Fertility Center was founded in 2008 and has had an alliance with Olive Fertility, one of Canada's leaders in IVF medicine and a partner of The Fertility Partners. "We're excited to continue our relationship with Olive Fertility, and expand our relationship with The Fertility Partners, an organization known for their collaboration." The partnership with The Fertility Partners will allow us to build our knowledge and continue our commitment to innovation and expert fertility services," said Dr. Katherine Wise, the co-founder and Medical Director at KRFC.
"We admire KRFC's commitment to the growth and innovation of fertility services and to patient-centered excellence and believe they will strengthen our platform for future growth." TFP Chief Medical Officer Dr. Al Yuzpe says, "The acquisition of KRFC reinforces our existing partnership and mutual commitment to high-quality healthcare."
About The Fertility Partners The Fertility Partners ("TFP") is a new venture creating a network of fertility clinics across North America. The combined group of companies includes 8 clinics and 20 locations across 5 provinces, further growth will include additional IVF clinic acquisitions, de novo clinics and the development of adjacent services. The company aims to be a world class business partner of choice for leading IVF and prenatal practitioners with the goal of achieving best clinical outcomes, operational excellence and exceptional patient experiences. TFP provides partner clinics with back office support and a collaborative, synergistic medical-scientific, professional and business environment.
About Aurora Reproductive Care Aurora Reproductive Care is a state-of-the-art fertility clinic located in heart of Saskatoon, Saskatchewan. Our new embryology lab contains state-of-the-art equipment and air quality technology, providing the ideal environment for embryo development. As the province's only comprehensive reproductive health care facility our mission is to provide the highest quality, compassionate reproductive health care possible in a comfortable, welcoming and inclusive environment. At Aurora, our dedicated team of professional and highly-trained physicians, nurses, laboratory, and support staff are committed to helping patients obtain the best possible fertility outcome.
About Kelowna Regional Fertility Center The Kelowna Regional Fertility Centre has a multidisciplinary team of doctors, nurses, laboratory technologists and andrologists who are trained in the area of infertility assessment and treatment.
Staying safe – Top 10 things Ontario doctors are asking you for this holiday season
TORONTO, Dec. 22, 2020 /CNW/ - All Ontario doctors want this holiday season is your continued safety and good health.
The best gift you can give is the gift of health. It's essential that everyone follow public health guidelines – handwashing, mask-wearing, physical distancing and the government's new shutdown restrictions – so we can spread cheer not COVID-19. The decisions we make during the next few weeks will have a direct impact on how many people get sick from COVID-19 as we head into a new year.
To keep your family, community and you safe, Ontario's doctors ask that you take these 10 steps:
1. Celebrate only with members of your household.
The virus spreads when people come into contact with each other. It is essential that you avoid gathering with anyone other than household members. If you live alone, you may consider joining one other household. This doesn't mean you can't connect with friends and family. Explore virtual options for celebrating together and create new virtual holiday traditions.
2. Support local businesses
Wherever possible, support local businesses by shopping online using curbside pickup and ordering takeout.
3. Wear a mask.
Wearing a mask protects you from spreading the virus to others. Keep your mask on unless you are home with your housemates or outside and can maintain a guaranteed minimum of two metres distance from others. Remember to wash your mask – and your hands – frequently.
4. Avoid travel.
Follow the government's shutdown restrictions and stay home. Do not travel between regions, provinces or countries except for essential reasons. Traveling poses a major risk as you could unknowingly carry the virus to a new region or bring it back to your community. This holiday, the best way to gather is virtually.
5. Continue to follow public health advice.
We know it is not easy, especially during the holiday season, but if we all follow public health advice, we can help stop the spread of COVID-19.
6. Get tested if you suspect you have COVID.
If you have confirmed or suspected exposure to COVID-19 or if you experience any COVID-19 symptoms, you must get tested for COVID-19. Testing is key to understanding where and how COVID-19 is spreading in the community. If there is a chance you may have COVID-19, getting tested and confirming your status is the best gift you can give your community.
7. Trace your contacts if you get COVID.
If you get COVID-19 you MUST trace your contacts so anyone you may have exposed to the virus knows to get tested. This also enables your public health unit to trace the virus transmission in your community. You can keep track of your contacts by downloading the COVID Alert app or manually logging the places you go and the people you come into contact with.
8. Connect virtually with others who may be lonely.
The festive season without in-person gatherings doesn't have to be lonely. Staying connected virtually with friends and family, especially those who are elderly, vulnerable or live alone is a great way to safely spread good cheer.
9. Take care of your mental health.
This season will be unlike any other and that can impact your mental health. Pay attention to how you are feeling and try talking about the emotions you experience. If you need additional support, seek care from a trained professional. Those you love may also be struggling with their mental health. If you are able, reach out to them virtually to listen and help them feel supported.
10. Talk about your health and safety concerns.
If you feel pressure to participate in an activity or gathering that doesn't make you feel safe, be honest about your concerns. If a loved one communicates their concerns about an activity to you, it is important that you listen to them and respect their wishes. Everyone is concerned about their health. The best gift you can give is to be honest about your intentions to protect your health and the health of those around you and to listen to others when they communicate their intentions to you.
The Ontario Medical Association represents Ontario's 43,000-plus physicians, medical students and retired physicians, advocating for and supporting doctors while strengthening the leadership role of doctors in caring for patients. Our vision is to be the trusted voice in transforming Ontario's health-care system.
SOURCE Ontario Medical Association
Hey Guys!
Alicia here! I get asked by my clients all the time what do I need for show day?!
Whether you are a first-time competitor or a returning competitor, preparing for your competition and making sure to remember everything that you need can be stressful.
Even if you have competed before you might have not been aware of some of the “must haves” that will benefit you for your big day.
For your upcoming competition, you are definitely going to want to make sure you have all of these show day necessities. It can be difficult to think of everything you should pack but don’t stress, I have got you covered.
The following list will keep you on top of your game for show day.
Coalition Representing Minority Communities Sends Letter to Congressional Black Caucus: 2020-2025 Dietary Guidelines Risk Excluding People of Color
Signers Include American Psychological Association, Grapevine Health, NAACP, National Hispanic Medical Association, Native American Agriculture Fund, The Nutrition Coalition, WANDA: Woman Advancing Nutrition Dietetics and Agriculture
Washington, D.C. – The Food 4 Health (F4H) Alliance sent a letter to the Congressional Black Caucus (CBC) highlighting a recent F4H report that found more than 90% of the systematic reviews in the Scientific Report by the 2020 Dietary Guidelines Advisory Committee did not account for race, ethnicity, and/or socio-economic status. The report also found the Committee relied predominantly on white populations that are questionably generalized to the broader U.S. population.
In light of these findings, the letter urges the CBC to impress upon Congress and the agencies-- the U.S. Departments of Agriculture and Health and Human Services (USDA-HHS)-in charge of the Dietary Guidelines for Americans (DGA) the importance of ensuring that the Guidelines serve all Americans.
The signers of the letter include the American Psychological Association, NAACP, National Hispanic Medical Association, Native American Agriculture Fund, Grapevine Health, The Nutrition Coalition, and WANDA: Woman Advancing Nutrition Dietetics and Agriculture.
The letter states: “According to a recent report by the Food4Health Alliance, more than 90% of the scientific reviews conducted for the 2020 DGA did not account for race, ethnicity, and/or socio-economic status. The disturbing implication is that the 2020-2025 Dietary Guidelines for Americans may not be appropriate for historically disadvantaged populations” said Simona James, spokesperson for the Food 4 Health Alliance.
“The Dietary Guidelines have far-reaching influence over our country’s eating habits, but do not actually account for most of our population. This policy cannot afford to exclude those who struggle with chronic diseases—the majority of our nation— including the most vulnerable among us,” added James.
Providing nutritional advice for those with obesity, diabetes, and other chronic diseases should be reflected in federal nutrition guidance. However, the DGA is focused exclusively on disease prevention for healthy Americans. The DGA does not advise on treatment; it, therefore, excludes the more than 60% of Americans who have been diagnosed with at least one diet-related chronic disease.
According to the latest government data, 42.8% of American adults now have obesity, and these rates are 24% higher among Hispanics and African Americans. The rate of diabetes also continues to be significantly higher among racial minority groups. Native Americans (American Indians and Alaska Natives) have a greater chance of having diabetes than any other US racial group, and Pacific Islanders are 2.5 times more likely to get diagnosed with diabetes than white populations.
“Research shows that a lifetime of malnourishment to crucial micronutrients and an imbalance of macronutrient intake predisposes us to nutrition related and inflammatory diseases. These diseases are not only at epidemic levels in Tribal communities, they are expensive and unnecessary. A more preventative approach to informing feeding programs will ensure a better quality of health for Native people and all Americans,” said Valerie Segrest, BSN, MA, Regional Director, Native Food & Knowledge Systems, Native American Agriculture Fund.
“As minority Americans become the new majority by 2050, our nutrition policies and practices such as the DGA should reflect the growing demographic to eliminate health disparities. For instance, the 5-year federal research plan has yet to invest in African heritage foods as it has with other cultural diets. We need more data to support new recommendations in the DGA to achieve health equity in this country,” said Tambra Raye Stevenson, MPH, CEO WANDA.
The COVID-19 pandemic brings greater urgency to addressing these chronic diseases such as obesity, heart disease, depression, and diabetes, which have clearly been linked to an increased risk to COVID-19 complications including hospitalization, intubation, and death. Higher rates of these chronic diseases among disadvantaged and communities of color are likely a factor in explaining the greater rates of COVID-19 seen in these groups.
Rigorous scientific studies have shown that the healthful food choices as well as greater access to those foods in low-income neighborhoods, among other social determinants of health, can start to reverse hypertension and type 2 diabetes within a matter of just weeks.
“Greater investment should be made in researching and understanding individual eating habits so that our nutritional guidelines can move from a "one-size fits all" approach to one that is inclusive of all Americans. There is a lack of cultural representation in the Guidelines - and to not include studies that consider race/ethnicity limits their applicability and relevance to underserved communities. One’s culture plays a role in food choices, and these attitudes/beliefs should be reflected in the research methodology when creating recommendations,” said Lisa K. Fitzpatrick MD, MPH, MPA, Founder and CEO of Grapevine Health.
Dr. Myles Spar, integrative men’s health specialist and chief medical officer at Vault Health, says: “Men should see 2021 as a chance for a clean slate. It’s never too late to develop better lifestyle habits and evaluate your goals when it comes to your sexual, physical, and cognitive performance.”
Vault is the first men’s telehealth company to provide personalized treatments and testosterone replacement therapy for men in the comfort of their own home, and their team of health experts surveyed 2,000 U.S. men ages 30-65 to find out about their New Year’s resolutions for 2021.
Some shocking (and some not-so-shocking) insights were revealed.
>> THE DAD BOD IS OFFICIALLY OUT OF STYLE. Getting rid of problem belly fat tops the list of men’s resolutions. Approximately 65% said their number one New Year’s resolution was to get into better shape and shed unwanted pounds (particularly in the belly region) next year.
The top five states where men said their top New Year’s resolution is to get rid of problem belly fat are:
Dad Bod Resolution Rankings
Texas – 88%
Illinois – 87%
Florida – 85%
Nevada – 84%
Pennsylvania – 82%
>> SEXUAL PERFORMANCE IS A TOP PRIORITY FOR MEN IN RELATIONSHIPS. Roughly 66% of men said their romantic partner would benefit if it was easier for them to get and stay aroused in the new year, and an almost equal number of men (65%) said their romantic relationships would benefit if their sex drive/ libido was higher in the new year.
And, if men played the worst ever hypothetical game of ‘Would You Rather?’ having to choose between being obese or having erectile dysfunction during all of 2021, a whopping 2/3rds of men said they would rather be obese. Vault’s survey also found that 61% of men don’t like going to the doctor, and 40% are too embarrassed to ask their doctor overly personal health-related questions.
Dr. Spar says: “The number of men that would rather be obese than have erectile dysfunction really speaks to the stigma around men’s performance-related sexual health issues, and their unwillingness to open up to medical professionals about it. Our service was designed by men, for men, and helping men achieve their optimal sexual, physical, and cognitive performance is at the heart of everything we do.”
>> MORE ENERGY IS A TOP ITEM ON MEN’S 2021 SELF-IMPROVEMENT ‘WISH LIST.’ When asked about health-related ‘wish list’ items for 2021, 28% of men said that more energy was their top priority (second only behind decreasing body fat). Additionally, 61% of men said their current energy level is lower now than it was five years ago, and more than 77% of men also said their romantic relationship would benefit in 2021 if they had more energy.
>> HEALTHY HABITS CONTINUE TO BE A TOP PRIORITY FOR MEN. A whopping 91% of men say they plan on making health-related New Year’s resolutions this year and 52% of them say they do so every year. They are also pretty confident of their success with roughly 61% saying they think they will be successful in accomplishing those health-related resolutions.
“The thing many people neglect to realize is that they can’t be successful in achieving their health or fitness-related New Years’ resolutions if they don’t first evaluate their body composition to know where they stand. To ensure a new health regimen is effective, it’s important for men to know their testosterone levels, body fat percentage, and other important health indicators,” says Dr. Spar.
For more vital men’s health information and details, check out www.vaulthealth.com.
COVID-Weary Nurses: Here Are 7 Ways to Stay Inspired in 2021
Rich Bluni, RN, says we can reconnect with meaning and purpose even in these dark times. Here are seven simple, yet powerful tactics to keep in mind as we head into a new year.
Pensacola, FL (December 2020)—2020 has been an unbelievably tough year for nurses. And while can hope for a better 2021 we’re painfully aware there are no guarantees. So as we step into an uncertain new year, how can we find the inner strength to keep going and show up in the way our patients deserve? Rich Bluni says the only possible answer is to purposely reconnect with that sense of purpose, meaning, and mission—that sense of calling—that drives us.
“That doesn’t ‘just happen’ even in good times; it’s a choice we must make every day,” says Bluni, himself an RN with over 25 years of experience in the ER, Trauma, and ICU and author of best-selling books Inspired Nurse (Huron|Studer Group Publishing, 2009, ISBN: 978-0-9749986-7-1, $24.95) and Inspired Nurse Too (Huron|Studer Group Publishing, 2016, ISBN: 978-1-6221804-6-2, $28.00). “And in times like these, it’s a choice we need to make every hour, sometimes every minute. If we don’t, we will quickly get overwhelmed by pain, fear, and negativity.”
Bluni—who last spring shared stories and tactics from Inspired Nurse in short video segments—says hard times contain moments that can deeply inspire us if we make a point of staying open to them. Here, he offers a few tips for reconnecting with your inspiration in 2021.
Take 10 minutes to relive a moment when you made a real difference. In Chapter 1 ofInspired Nurse, Bluni recalls an incident he’s titled “The Day the Nurse Stood Still.” He was driving when a car flipped over on the freeway and he rushed to help a desperate mother and her dying baby. In the midst of all that blood and panic, he managed to resuscitate the baby. Now, when he is having a tough time, he relives the whole incident—the sounds, the sights, the emotions, and especially the joy he felt when the baby started breathing again.
“You can do the same,” he says. “Throughout your day, at any moment when you’re feeling crushed and exhausted, like you can’t go on, close your eyes, take a breath, and be right back there when you saved a life or did something incredible. Relive your greatest moment. Your mind doesn’t know the difference between it really happening and the memory.”
Write down your gratitude… Even in a pandemic, there are things to be grateful for. Maybe a patient you thought was going to die actually recovered. Maybe a coworker paid for your lunch. Maybe the cafeteria had that carrot cake with the cream cheese frosting you love. Charting those moments of gratitude (however big or small) not only does wonders for your mindset, it helps you remember why you chose this deeply meaningful line of work.
“Whether it’s in a journal, a notepad, or on a sticky note, write down three things about your work that you are thankful for every day,” says Bluni. “Each day, look it over and add to your list. It’s not an exercise in ‘woo-woo feel-good fluff’; it is a powerful tool to recalibrate yourself when you are hurting. Getting yourself into a state of gratitude takes away the ability to be in a state of negativity. You almost cannot be in a state of gratitude and negativity at the same time, but you can choose.”
…then, share it with others. Chances are, some of the “things” you find yourself writing on your gratitude list are actually people. Maybe it’s the coworker who always jumps in to help, the unit secretary who runs your labs for you when you’re swamped, or the food service employee who always remembers your lunch order.
“Extend your gratitude to someone every day,” advises Bluni. “Give them a thank-you note, tell them face-to-face—even if it has to be from 6 feet away while wearing full PPE!—or send a note to their supervisor praising their awesome attitude. Not only will you feel better, you’ll help others feel better at a time when most likely they really need it.”
Make a self-care plan. Even in the best of times, nurses are so busy being caregivers to our patients, our students, our peers, our employees, and even to our friends, communities, and families that we rarely extend the same courtesy to ourselves. Right now, it’s more important than ever to set goals that will change your life in a positive way.
“Set aside an hour or so, maybe on a day off, if you’re getting those these days,” suggests Bluni. “Get out a journal or pad and write the following labels on five separate pages: Mind, Body, Spirit, Love, and Prosperity. Under each title, come up with just two things that you can do, change, read about, or experience every day that would impact that part of your being. In the ‘Body’ category you may write, ‘walk a mile,’ ‘eat more green veggies,’ and ‘drink eight glasses of water.’
“Each week, focus on taking action in those areas, even if it’s one very small action,” he adds. “It may feel strange to focus on improving your life at a time when the world seems to be falling apart, but now is when we need to be at our best. Give yourself every advantage. The old cliché about airplane safety tells us that when an oxygen mask falls, we are supposed to put it on ourselves first and then put a mask on someone who needs help. That’s literally the opposite of what a nurse is all about, but in times like these especially, you simply have to find a way to take care of yourself in order to be able to do the things we are being called on to do today.
“And for the love of all things…go easy on yourself! Nurses hold themselves to the highest of standards—and we should—but don’t do that at the expense of your mental and physical health! I know we all want to be perfect, but that’s a bar too high. In the middle of a pandemic, maybe strive for ‘panderfect’! What I mean is not lowering your standards of safe care or anything like that, but don’t beat yourself up if you’re not your usual self. Be your best. Give your best. But, please, be kind to you!”
Get intentional about who you spend time with. Who do you chat with on breaks during your shift? Who do you sit next to in the cafeteria? Who do you vent to when times are tough? Often, we don’t make these decisions consciously; they’re as much a part of our routines as, well, getting dressed and going to work. The problem is, we might be hanging out with psychic vampires who drain our life force and break us down with their negativity.
“Your two most valuable resources are your love and your time,” Bluni says. “So if you’re spending them on people who spread fear, or hold grudges, or don’t act in ways that are kind and compassionate, I encourage you to become more intentional about your relationships. Really think about who lifts you up and who brings you down, who gives you hope and who takes it away. The company you keep has a big impact on your attitude and well-being.”
Stop blaming yourself for others’ difficult behavior. All nurses have plenty of experience dealing with the occasional patient or family member who is grouchy, ungrateful, demanding, or even downright mean. And because we’re so committed to providing the best care, we often take their difficult behavior personally. What could I have done better? What did I do to provoke that comment? Should I have spent more time explaining the medication’s side effects? Etc.
“Realize that 99 percent of the time, difficult patients aren’t reacting to you but to their circumstances,” Bluni reminds. “The real antagonist is their pain, fear, lack of mobility, etc.—and as a caregiver, you’ve simply been caught in the crossfire. Try not to take their bad mood personally. Easy to say…hard to do. Here’s the thing: If you believe someone is doing or saying something out of spite, you certainly feel a certain way toward them. Who wouldn’t? But, if you believe that someone is doing or saying something out of fear, then your whole outlook changes. If your child screams at you because they’re angry, you may react in a certain way, versus if they scream because they are having a bad dream, or are scared of a loud noise…your compassion reflex is immediately triggered. People are scared right now. Most of us are scared right now. Knowing that gives you a different perspective.”
Realize that you don’t rent your life. You own it. Would you ever rent a car and then immediately take it to a mechanic to pay for a tune-up, tire rotation, and then a good wash and wax? Of course not. But is this how you treat your work life? Do you let bad situations and other people’s negativity dictate how you feel? If you do, then you’re renting. If you want to have a more inspirational work life, decide to be more focused on inspiration.
“You can’t wait around for someone to rescue you or to fix how you feel,” says Bluni. “Start by practicing gratitude and improving yourself. Connect with other people every chance you get. Opportunities to do so exist around each corner in healthcare. We forget how abundant these chances are because they are almost too obvious. Look for inspiration today. Look for ways to give. Own your life—especially right now.”
If you lean into the vital work you’re doing right now and find a few moments to take care of you…you may come out on the other side with a whole new perspective.
“It’s when times are toughest that we learn the most valuable lessons and experience the biggest leaps in our personal growth, as painful as it may be, as scary as it may be,” says Bluni. “If there’s one thing that has been made abundantly clear throughout all of this, it’s that nurses are the most resilient, compassionate, and inspiring people on this earth…and the world is seeing that clearer than ever. That’s one bright spot we can be grateful for.”
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About the Author: Rich Bluni, RN, is the author of the best-selling books Inspired Nurse, Oh No…Not More of That Fluffy Stuff!, and Inspired Nurse Too. He has an active and popular Facebook page called Inspired Nurse.
Rich has been an RN since 1993. He has worked as a nurse in Adolescent Oncology, Pediatric ICU, and Trauma ICU departments as well as serving as a pediatric flight and transport nurse. He has served as an ED nursing manager as well as a senior director of risk management, quality, and patient safety.
He came to Studer Group in 2007 as a coach working with dozens of healthcare organizations and leaders to drive outstanding results. He is presently a senior director with Huron and a Studer Group national speaker, having traveled across North America to speak in front of hundreds of thousands of healthcare workers and leaders in hundreds of healthcare organizations, large healthcare conferences, as well as virtual webinars.
Russell Alexander Law Firm Warns That Covid-19 Vaccine Could Lead to Disputes Among Divorced Parents Collaborative family law firm outlines legal rulings that set parameters
LINDSAY, Ontario—Russell Alexander Collaborative Family Lawyers warned that the upcoming coronavirus vaccines could lead to disputes among divorced parents over whether each caregiver and the child are vaccinated.
“The coronavirus pandemic has introduced a lot of complications to parenting agreements, and we should expect something similar as the Covid-19 vaccine is rolled out,” said founder Russell Alexander. “In this case, there is a lot more guidance that we can rely on, however.”
Alexander said that past court decisions on routine vaccinations and provincial and national laws on health care workers will resolve personal disputes between parents who are skeptical and those who are supportive of vaccination.
With at least three vaccines being prepared for distribution early next year, polls show the majority of Canadians wish to get vaccinated. In a recent Ipsos poll, 61 percent even said they support mandatory vaccinations.
But, as with any vaccination, there are parents who are skeptical of the science that shows vaccines prevent disease, which can cause a clash with those concerned about the health of their children. In the past, Canadian courts have ruled that the typical “due diligence” requirement for major decisions on children’s health may be relaxed in the case of a vaccine as it relates directly to their physical and mental welfare.
“Courts generally recognize the science behind vaccines, which should boost parents who wish to keep their child healthy in any dispute,” said Alexander.
He noted that in a recent case involving the coronavirus pandemic, a court split decision-making authority between separated parents, giving custody to the mother but giving the father the express right to make the final decision on whether their child was vaccinated for the coronavirus when a vaccine becomes available. Russell Alexander is author of the new book, "Everything You Always Wanted to Know About Divorce," which includes a bonus chapter on divorcing during the pandemic.
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RussellAlexander Collaborative Family Lawyers
Russell Alexander Collaborative Family Lawyers is committed to practicing exclusively in the area of family law in Ontario dealing with all aspects, including separation and divorce, child custody and access, spousal support, child support, and division of family property. A team of lawyers provide guidance from start to finish, helping clients identify and understand the legal issues as well as the options and opportunities available through the transition. The firm has offices in Lindsay, Whitby, Oshawa, Markham, Peterborough and Toronto, Ontario. For more information, visit: http://www.russellalexander.com
Blood alcohol levels much lower than the legal limit impair hand-eye coordination
FOR IMMEDIATE RELEASE
In previous studies, eye movements and vision were only affected at blood alcohol concentrations (BACs) approaching the legal limit for driving (0.08% BAC), in England, Wales and Northern Ireland (1).
New research published in The Journal of Physiology however found for the first time that hand-eye coordination is dramatically more sensitive to alcohol with some measures of coordination impaired by more than 20% at BAC levels as low as 0.015%.
In particular, the ability to process visual motion, which is crucial for hand-eye coordination in driving and other activities, is compromised after consuming the equivalent of less than a half of beer, for a person around 75 kilograms in weight.
The findings from the research team based at NASA’s Ames Research Center provide new information on the potential impact of even minimal alcohol consumption on high-risk human activities that rely on keen visual and visuomotor control, like driving, piloting, or working heavy machinery.
NASA is interested in developing sensitive yet non-invasive methods for detecting mild impairments. The researchers used low-dose alcohol to mildly, and reversibly, impair brain function as a proxy for other stressors that could affect performance in aerospace settings, such as altered gravity or atmospheric conditions, or in earth-based situations, such as neural illness, head injury or sleep deprivation.
Using this technique, they show that a set of eye measurements represents an ultra-sensitive new approach for detecting performance deficits, valuable for studying brain impairments in people on Earth and also in space.
Apart from this finding specific to alcohol-induced impairment, this study further demonstrates how a specially designed collection of non-invasive eye measurements can be used to measure mild deficits of processing in the brain.
To conduct the study, the researchers measured volunteers’ eye movements, pupil responses, and BAC, multiple times during a day while they performed a specially designed task, before and after they drank alcohol.
At random, the volunteers were assigned a mixed drink containing a certain quantity of alcohol achieving either the higher (0.06%) or lower (0.02%) peak BAC levels so that they were not aware of exactly how much they drank on a given day.
The special task involved looking at a set of stationary points on a computer screen, then following with their eyes a dot that moved in a random direction, at a random speed. The dot started moving at a random time so that guessing did not help.
The researchers then computed 21 different ocular measures that have been shown to assess neural processing in specific brain areas that contribute to different components of the eye-movement and pupillary responses.
The study participants were men and women, mostly in their 20s, who drink on average 1-2 drinks per week. Therefore, the researchers haven’t looked at the impact of age, nor have they tested heavy drinkers. The researchers made sure that participants had a full-night's sleep the night before, and asked that they abstain from both alcohol and caffeine consumption for several nights in a row prior to testing.
In future studies, the researchers plan to look at how their eye measurements are affected by other types of neurological conditions, such as those caused by degenerative diseases or toxic exposures. By using alcohol as a heuristic reference, they’ll be able to compare any new-found impairments to that caused by consuming a certain number of alcoholic beverages.
Terence Tyson, first author on the study, said:
“Our findings provide a cautionary tale that the subjective experience of drunkenness is often not aligned with objective impairment of sensorimotor coordination. In other words, most people feel they are unimpaired after one drink, yet they are to a significant degree.”
Thus, driving may be affected by drinking just a small amount of alcohol, even though the driver may feel fine and be well within the legal limit.
Full paper title: Dose‐dependent sensorimotor impairment in human ocular tracking after acute low‐dose alcohol administration; Link to paper https://physoc.onlinelibrary.wiley.com/doi/abs/10.1113/JP280395 (link will only work after the embargo date. Before then, please email the press office for a copy of the paper)
The Journal of Physiology publishes advances in physiology which increase our understanding of how our bodies function in health and disease. http://jp.physoc.org
The Physiological Society brings together over 4,000 scientists from over 60 countries. The Society promotes physiology with the public and parliament alike. It supports physiologists by organising world-class conferences and offering grants for research and also publishes the latest developments in the field in its three leading scientific journals, The Journal of Physiology, Experimental Physiology and Physiological Reports. www.physoc.org
ams and Precision Biomonitoring announce global partnership to enable pandemic control through the development of a rapid saliva antigen testing device for Covid-19 (SARS-CoV-2)
The easy-to-use, lab-free Covid-19 (SARS-CoV-2) antigen test solution aims to provide reliable results in around 15 minutes at the point-of-care
The objective is affordable, rapid mass testing by analyzing saliva samples and allowing digital results to be uploaded to a medical cloud
Innovative approach using ams spectral sensor to enable higher readability and unambiguousness of results // enable more easily readable and unambiguous test results
Initial results, on inactivated virus particles, indicate a very good sensitivity in the order of cycle time (CT) 31, which could lead to the identification of asymptomatic persons
PREMSTAETTEN, Austria and GUELPH, ON, Dec. 21, 2020 /CNW/ - Today, ams (SIX: AMS), a leading worldwide supplier of high performance sensor solutions, and Precision Biomonitoring, a Canadian-based leader in virus detection tools, announce a global partnership to share technologies to develop an innovative testing device for the Covid-19 (SARS-CoV-2) virus. The partnership will see ams' innovative spectral sensor technology paired with Precision Biomonitoring's lateral flow and digital capabilities. The combination is expected to re-imagine mass testing devices for Covid-19 (SARS-CoV-2). Initial results, on inactivated virus particles, indicate a very good sensitivity in the order of cycle time (CT) 31, which could lead to the identification of asymptomatic persons.
"The pandemic is still with us and will continue to be part of our lives well into the new year. This partnership with ams will continue to provide innovative solutions urgently needed by government and authorities to help track and control this virus," says Dr. Mario Thomas, CEO, Precision Biomonitoring. "We are dedicated to developing quality testing devices and with the addition of this highly-sensitive technology we will continue to change the testing landscape."
To create innovative solutions and support pandemic control, ams and Precision Biomonitoring are investigating the efficacy and sensitivity of a lab-free lateral-flow test connected to a medical cloud, to detect virus particles in as little as around 15-minutes. The test is focused on detecting the virus at earlier stages of infection, before symptoms have appeared.
The ams spectral sensor solution allows fluorescence-based read out of antigen detection, strengthening ams' leadership in delivering high-quality professional health diagnostics, designed to improve speed and reliability of rapid, point-of-care diagnostics.
"Governments and authorities need to enable fast, reliable and effective testing. Our initial results for this solution indicate that even asymptomatic patients who carry the virus could be more readily identified. We expect the combination of Precision Biomonitoring and ams technology to become an essential tool in the effort to help control the pandemic and resume the many economic and social activities that comprise what we call normal life," says Jennifer Zhao, Executive Vice President, division Advanced Optical Sensors, ams. "This is aided by the fact that, once approved, the testing solution can be produced inexpensively and without complex limitations at high scale. We hope that this solution will eliminate complicated logistics and clinical processes and streamline approaches to mass testing."
About ams ams is a global leader in the design and manufacture of advanced sensor solutions. Our mission is to shape the world with sensor solutions by providing a seamless interface between humans and technology.
ams' high-performance sensor solutions drive applications requiring small form factor, low power, highest sensitivity and multi-sensor integration. Products include sensor solutions, sensor ICs, interfaces and related software for consumer, communications, industrial, medical, and automotive markets.
With headquarters in Austria, ams employs around 9,000 people globally and serves more than 8,000 customers worldwide. ams is listed on the SIX Swiss Exchange (ticker symbol: AMS). More information about ams can be found at https://ams.com
ams is a registered trademark of ams AG. In addition many of our products and services are registered or filed trademarks of ams Group. All other company or product names mentioned herein may be trademarks or registered trademarks of their respective owners. Information provided in this press release is accurate at time of publication and is subject to change without advance notice.
About Precision Biomonitoring Founded in 2016 by a team of scientists from the University of Guelph's Biodiversity Institute of Ontario, Precision Biomonitoring provides TRIPLELOCK™ onsite eDNA surveillance platform solutions that give customers earlier detection of organisms for a more rapid response. Customers are any organizations that need onsite surveillance and rapid identification of any organism in any environment. The Precision Biomonitoring team is at the forefront of technological innovations in the genomics industry. Our vision is a world where we can identify any organism on the spot, in an instant, anywhere on the planet. https://precisionbiomonitoring.com
SOURCE Precision Biomonitoring
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