Gluten Pioneer Says Food Labeled ‘Gluten Free’ Isn’t Always What You Think
Think you’re following a gluten-free diet? Not so fast.
A physician who is a pioneer in discovering and diagnosing the problems with gluten says many products touted as gluten-free today are not.
Dr. Kenneth Davin Fine, a gastroenterologist, and creator of Oro-Intestinal Fitness Products (www.finerhealth.com) and the Gluten/Food Sensitivity Diagnostic Laboratory EnteroLab.com brought gluten sensitivity to the public consciousness more than 20 years ago.
He says during those early years, gluten-sensitive patients usually experienced significant improvement in their health on a “gluten-free diet” but his patients have told him in recent years they have seen fewer improvements.
“Products can now be labeled ‘gluten free’ even if that food contains up to 20 parts per million of gluten,” Dr. Fine says. “While that doesn’t sound like a lot, a little gluten can go a long way in the reactions of the most active immune systems.”
Gluten is a protein found in the cereal grains wheat, barley, rye, and oats. It is a mixture of proteins and causes illness in people with either celiac disease, when the immune reactions to gluten damage the intestinal tissues visible on a biopsy, or more commonly non-celiac gluten sensitivity. This happens when symptoms and intestinal dysfunction are present in the absence of such changes on a biopsy.
Recent studies found that most (but not all) celiacs could eat gluten without resulting in damage to their small intestine. In his research, Dr. Fine has found that only about half of celiacs or non-celiac gluten sensitive patients can tolerate oats. He says “gluten-free oats” is a misnomer and may be responsible for symptoms experienced by people who think they are eating a gluten-free diet.
Dr. Fine believes the gluten sensitivity epidemic is caused by:
- A combination of greater immunoreactivity in most people stimulated by mainly environmental factors (stress, exposure to hormones in food, medicines, pollution, and possibly EMS from electronic devices).
- The way many foods have been altered by producers so they can be manufactured in mass quantities more efficiently.
- Widespread use of stomach acid-inhibiting medicines.
- A general lack of breastfeeding in this country from 1955-1985 (when synthetic infant formula was falsely touted to be more healthy than breast milk).
- Public health directives recommending that the public should eat mostly grains as part of the USDA food pyramid.
- An evolution of agricultural practices leading to hybridization of grains to increase their gluten content, and more widespread use of herbicides and pesticides.
Recently, there also has been a significant increase in the mass marketing of products said to assist the gut microbiome in digesting food. The microbiome is the genetic material of all the microbes – bacteria, viruses, and fungi – in the body.
Dr. Fine says the best way to keep a healthy gut and microbiome is to eat the right foods. “Researchers have sometimes detected a different microbiome in obese individuals compared to non-obese individuals; although this has attempted to be the blame for the obesity, it cannot be ruled out that their microbiome is different because they make different, and perhaps less healthful food choices,” Dr. Fine says.
Other reasons for a poor microbiome are frequent exposure to antibiotics, the bactericidal chlorine added to public water, improper sleep, stress, and diets heavy in meat, cooked food (as opposed to raw vegetables/salads and fruit), and “junk food” and other sugar-laden foods. This is all typical of the modern lifestyle, which Fine says is a primary contributor to poor overall health.
“If you really want to achieve a healthy body, you must have a healthy intestine and intestinal flora,” Dr. Fine says. “And when it comes to immunologic food sensitivities, one must really be more restrictive of antigenic foods than was necessary years ago because of the progression of this immunologic epidemic.”
About Dr. Kenneth Davin Fine
Dr. Kenneth Davin Fine, the creator of Oro-Intestinal Fitness Products, (www.finerhealth.com), and founder of the patented gluten sensitivity testing method at EnteroLab.com is an academic gastroenterologist who has held staff positions at both Baylor University Medical Center and the University of Texas-Southwestern Medical School. His medical research has appeared in prestigious medical journals including The New England Journal of Medicine, Gastroenterology, The Journal of Clinical Investigation, and The American Journal of Gastroenterology. He has been professionally involved in patient care, medical research, teaching, directing clinical laboratories, nutritional pioneering and original health product and unique organic health food product development for almost 30 years.
CGPA Statement on Pharmaceutical Concessions in United States-Mexico-Canada Agreement
TORONTO, Oct. 1, 2018 /CNW/ - The following is a statement by Jim Keon, President of the Canadian Generic Pharmaceutical Association (CGPA), on the pharmaceutical intellectual property aspects of the United States-Mexico-Canada Agreement (USMCA):
Canada was not at the table when harmful intellectual property provisions were negotiated between the United States and Mexico. The pharmaceutical provisions in USMCA will delay access to competition from biosimilar biologic drugs. Biologic medicines represent the fastest growing cost segment of health-care spending, and these delays will be costly to patients, businesses that sponsor employee drug plans, private payers and our industry.
The United States-Mexico-Canada Agreement is disappointing for the vast majority of Canadians who feel access to more affordable prescription medicines is the most important aspect of the negotiations. A recent poll1 found that four in five Canadians feel that it is important that the negotiations should not delay Canadians access to more affordable versions of expensive biologic drugs. Four in five Canadians also say it's important that the agreement not create new barriers for the implementation of National Pharmacare in Canada.
While the Government of Canada says it is committed to improving access to necessary prescription medication and reducing the amounts Canadian governments pay for these drugs2 this is unfortunately not what they have achieved by agreeing to concessions that reduce access to essential medicines and increase costs for those who pay for drugs.
The USMCA pharmaceutical intellectual property concessions are the latest hit for access to affordable prescription medicines for Canadians. Canada's intellectual property regime for pharmaceuticals was amended in September 2017 as a result of the Comprehensive Economic and Trade Agreement (CETA) with the European Union. The Parliamentary Budget Officer has conservatively estimated that the two-year patent term extension included in CETA will cost Canadians more $500 million annually.3
The pharmaceutical intellectual provisions included in the final text are extensive, and other aspects of the text are concerning. The CGPA is conducting a comprehensive review of the text to ensure there are no additional negative consequences for the Canadian health-care system.
About the Canadian Generic Pharmaceutical Association
The Canadian Generic Pharmaceutical Association (CGPA) represents Canada's generic pharmaceutical industry. The industry plays an important role in controlling health-care costs in Canada. Generic drugs are dispensed to fill more than 71 percent of all prescriptions but account for account for only 21 percent of the $28-billion Canadians spend annually on prescription medicines.
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1 http://canadiangenerics.ca/news-release62/new-poll-canadians-strongly-agree-that-access-to-affordable-prescription-medicines-is-most-important-priority-for-nafta-2-0/
2 https://pm.gc.ca/eng/minister-health-mandate-letter
3 http://www.pbo-dpb.gc.ca/web/default/files/Documents/Reports/2018/Patent%20Restoration/Patent_Restoration_EN.pdf
SOURCE Canadian Generic Pharmaceutical Association
Healthy Lifestyle Habits Can Prevent Dementia
Chattanooga, TN, September 28, 2018 ― Dr. Timothy R. Jennings speaks expertly on a subject that concerns over 5.5 million people across the nation: how to prevent dementia and keep our mind sharp as we age. A psychiatrist and international speaker, Jennings introduces his new book, recently rated #1 by Amazon in books on dementia, The Aging Brain: Proven Steps to Prevent Dementia and Sharpen Your Mind.
Dr. Jennings prescribes simple, everyday actions we can take to stave off disease, promote vitality, and prevent dementia and late-onset Alzheimer's. "The choices we make now can help us to keep our minds sharp and maintain our independence as we age,” says Jennings.
An easy-to-use guide to maintaining brain and body health throughout life, The Aging Brain is based on solid, up-to-date scientific research, and the interventions discussed can prevent progression toward dementia, even in those already showing signs of mild cognitive impairment. The recommendations also may help reduce disability and depression.
"This book isn't just for people hoping to slow the aging process,” says Jennings. "It's also for anyone who is a caregiver to someone at risk of or already beginning to suffer from dementia. It offers a hopeful, healthy way forward.”
Jennings, who maintains a private practice in Chattanooga, TN, has authored several books, including The God-Shaped Brain and The God-Shaped Heart. He is a Distinguished Fellow of the American Psychiatric Association and Fellow of the Southern Psychiatric Association, and is president and founder of Come and Reason Ministries.
For more information about Dr. Jennings, please visit the website: https://www.agingbrainbook.com.
To connect with Dr. Jennings, please visit: https://www.facebook.com/DrTimJennings/ and https://twitter.com/timjenningsmd.
The Aging Brain: Proven Steps to Prevent Dementia and Sharpen Your Mind
Baker Books
Released: June 2018
ISBN-10: 080107522X
ISBN-13: 978-0801075223
###
TIP SHEET
Reviews for The Aging Brain: Proven Steps to Prevent Dementia and Sharpen Your Mind:
Dr. Caroline Leaf, Cognitive Neuroscientist, Communication Pathologist and Author: "Great advice and excellent science on aging! It's well worth following and applying these principles so as to age the way we are supposed to.”
Rodney A. Poling, MD, DFAPA, medical director, Behavioral Healthcare Center, Columbia TN., and board-certified geriatric psychiatrist: "A well-researched and commonsense book aimed at helping one understand the complexities of dementia, while offering recommendations for maintaining healthy brain function into our later years.”
Michael Lyles, psychiatrist, author, and speaker: "Dr. Jennings clearly describes how to practically manage the medical and lifestyle variables that can positively impact brain health and the process of aging. Age is a number, but getting old is a lifestyle.”
Jessie James Decker has no time for cheating rumors.
The country-pop superstar is continuing doing what she does best – running her empire…and officially launching her partnership with JustFab, which goes live TODAY. You can shop her favorite boot styles for fall at www.justfab.com/jjd.
Decker is kicking off her favorite time of year – BOOT SEASON – by releasing her aptly named new single, “Boots,” which is featured in her new JustFab commercial (get a taste straight from Jessie’s ‘gram here).
The Broadview Hotel unveils a monthly rotating menu at The Civic
The 127-year old historic landmark invites guests to experience delectable new dishes and cocktails
TORONTO, ON –
The Broadview Hotel’s restaurant,
The Civic, unveils a fresh seasonal menu inspired by Ontario’s homegrown flavours, embracing techniques traditional to Mennonite farm cooking, along with classic German and French cuisine. Rotating monthly to best highlight seasonal ingredients, the culinary team, led by
Chef de Cuisine Dave Couse, has crafted a menu that emphasizes the simplicity and diversity of traditional cooking.
“The idea behind a rotating menu is to offer guests seasonal flavours that are rooted in Ontario’s rich terroir,” says Couse. “We wanted to create an original experience that guests can enjoy every time they dine with us. For our team, it also allows us to flex our culinary creativity and design something new and exciting on an ongoing basis.”
This approachable concept will charm both new and returning patrons with a hyper-seasonal menu that accommodates all palates. Bringing traditional dining service to the forefront, guests are encouraged to converse with their servers, ask questions about dishes, ingredients, pairings and more.
Sure-fire starters for the September menu include Sweet Corn Velouté ($10) served with whipped mascarpone and brown butter popcorn; Cured Steelhead Trout ($13), a sweet and salty cured fish with radicchio purée and turnip and Roasted Grape and Kale Salad($14) with red quinoa and pickled kohlrabi for a lighter start to an aromatic dining experience.
Roasted Grape and Kale Salad
Photo credit: Kayla Rocca
Each monthly menu embraces the vibrant flavours of the season with bird, game and seafood. Highlights from the September menu include Roasted Mennonite Hen ($27) providing an Oktoberfest flavour profile with rye spätzle, sweet onion, carrots and grainy mustard; Confit of Wild Boar Shank ($36) with glazed maple, hasselback potato, earthy cabbage and an abundance of fresh chives; Atlantic Salmon ($28) accompanied by shaved fennel slaw, salmon caviar and fresh dill and sorrel; and Crispy Skin Sablefish ($34) alongside potato gnocchi tossed in dandelion haché, and savoury beefsteak tomato broth.
Confit of Wild Boar Shank
Photo credit: Kayla Rocca
Cap the meal off with The Civic’s new desserts, fashioned by Pastry Chef Sarah Battyethat will satisfy every sweet tooth. Indulge in the Tres Leche ($9), featuring soft sponge cake with maple sugar macerated plum, and white chocolate milk crumble. Craving something a little fruitier? Try the Raspberry Sachertorte ($12) with raspberry purée and dark chocolate glaze drizzled on a slice of rich chocolate cake – or the Pavlova ($10), a lighter “crispy on the outside, soft on the inside” meringue presented with fresh berries and Chantilly.
Bee Charmer
Photo credit: Kayla Rocca
To complement the updated seasonal fare, The Civic is offering a rotating cocktail menu, conceptualized by
Head Bartender Tony DaSilva. Indulgences include
The Bookshop Casanova ($14), featuring Botanist gin, pisco, lemon juice, falernum, orange flower water and nutmeg; the
Bee Charmer ($16) with strawberry-infused Cazadores Reposado tequila, honey syrup with prosecco and bee pollen sugar; while the
Garden of Eden ($14) is prepared with olive oil washed vodka, Dolin Dry Vermouth, pino mugo with a touch of bitters and basil. Further, the wine list shines a spotlight on well-known grape varietals from across the globe.
In addition to dining à la carte, guests can enjoy a five-course tasting menu highlighting monthly feature dishes. This allows diners to experience more of the innovative creations in one delectable sitting. For larger groups and families, The Civic offers family-style plating to allow guests to sample several menu items in a shareable format. Additionally, The Civic unveiled a new brunch menu for weekenders served Saturdays and Sundays.
“The Civic is a community gathering spot. These exciting changes offer our guests an engaging dining experience,” says Murray Henderson, General Manager, The Broadview Hotel. “Whether they’re here for a casual meal with friends and family or want to celebrate a milestone, The Civic embodies the true ‘civic centre’ of the east end.”
Reservations for The Civic can be made online at thebroadviewhotel.ca. For large groups please contact dinewithus@thebroadviewhotel.ca or call (416) 362-8439. For hours of operation, to view the menus or for more information, please visit thebroadviewhotel.ca. Reservations for holiday parties in The Civic can be made at 416-644-9589.
Click here to access hi-res images.
Website: thebroadviewhotel.ca
Instagram: @BroadviewHotel
Twitter: @BroadviewHotel
Facebook: The Broadview Hotel
Hashtag: #BroadviewHotel
About The Broadview Hotel
Located in the heart of Riverside at the corner of Queen St. E. and Broadview Ave., The Broadview Hotel is a boutique hotel, The Civic restaurant, lobby Café + Bar and Rooftop. The Romanesque Revival-style building constructed in 1891 is a heritage property, as designated by the City of Toronto. Cleverly reimagined as a charismatic gathering spot, each space is infused with the spirit of the east end: it’s a place where international travellers relax alongside local residents. Drawing from The Broadview’s iconic façade, visitors and community members will enjoy a uniquely crafted hospitality experience.
Youth Suicide Statistics
• Suicide is the SECOND leading cause of death for ages 10-24. (2016 CDC WISQARS)
• Suicide is the SECOND leading cause of death for college-age youth and ages 12-18. (2016 CDC WISQARS)
• More teenagers and young adults die from suicide than from cancer, heart disease, AIDS, birth defects, stroke, pneumonia, influenza, and chronic lung disease, COMBINED.
• Each day in our nation an average of over 3,041 suicide attempts are made by young people, grades 9-12. If these percentages are additionally applied to grades 7 and 8, the numbers would be higher.
• Four out of Five teens who attempt suicide have given clear warning signs.
• The Youth Risk Behavioral Surveillance System (YRBS) is a survey, conducted by the Centers for Disease Control and Prevention, that includes national, state, and local school-based representative samples of 9th through 12th grade students. The purpose is to monitor priority health-risk behaviors that contribute to the leading causes of death, disability, and social problems among youth in the United States.
What is being done to stop and/or reverse this enormous and growing trend?
International Suicide Prevention (ISP) has been successfully treating suicidal thoughts since 2006.
ISP is the only suicide prevention organization to be using advanced cognitive neuropsychology treatments that have been proven to work on suicidal ideation.
At the forefront of this epidemic ISP is developing the first of its kind, self-help suicide prevention mobile app that will treat suicidal ideation among teens.
The first step in the development stage is geared to target adolescents ages 5 to 24. Afterwards, ISP is expected to expand this program to include: veterans, military, first responders and seniors.
This has all been made possible with the help of behavioral modification scientist Matthew Dovel. Mr. Dovel has been working in the field of cognitive neuropsychology for over 3 decades. He is responsible for discovering a code that unlocks the secret to effectively modifying human behavior.
“Prejuvenation” 6 Things Millennials Can Do to Maintain Their Youth
Many people in their 20’s are stressed out about high post-college student loan debt requiring long work hours and side hustles to pay it off. They’re noticing their work hard play hard lifestyle is leading to tired eyes and premature wrinkles. They turn to filters to optimize their social media photos. Many are influenced by celebrities their age not to mention the countless millennial “social media influencers” who are setting the new standard for beauty and youth. Bottomline, millennials are stressed, and they don’t want to look it. Dr. Manesh Shah, Board-Certified Plastic Surgeon who specializes in facial plastic surgery urges the under 30 crowd not to overdo it with expensive treatments and procedures that can actually make them look older and put them further into debt. Here is his list of 6 things millennials can do to maintain their youth.
- Use sunblock every day.
“The best way to make sure your face is protected from the sun is to use a daily moisturizer with SPF of no less than 30,” explains Dr. Shah. He also suggests applying creams to your neck and chest to postpone wrinkling and sagging in these areas. “The sun protection done daily in your 20’s will pay off greatly in your 40’s,” he says.
- Get your Vitamin C.
“Vitamin C is a huge collagen booster and it also reduces pores and brightens skin, and these are the exact things women in their late 30’s and 40’s complain about most,” he reveals. Foods such as cantaloupe, mango, pineapples, oranges, grapefruits, and berries are all packed with this antioxidant which when eaten regularly does wonders to sustain a youthful glow.
- Ditch the fast food and eat more fish.
Those late night post partying fries and pizza are to be expected and at 25 are difficult to avoid. Perhaps your metabolism can handle it, for now. Offset these weekend indulgences by eating fish during the week. “Fish oil has fatty acids can erase early wrinkles you may notice. It prevents inflammation which can only make wrinkles more noticeable and deeper over time. A lot of millennials who are picky eaters and avoid seafood can get Omega-3’s via supplements but getting it directly from eating fish is best,” Dr. Shah suggests.
- Quit smoking.
Nothing will age you quicker than smoking. “It is possible for a 25-year-old to look 8-5 years younger, within just 3 months after quitting smoking. This number increases after age 30. Women over age 40 who don’t smoke typically look up to a decade younger than their counterparts who still smoke,” says Dr. Shah. There are a gazillion reasons to quit smoking. Linking it to vanity is a pretty powerful motivator.
- Decrease your sugar intake.
You really want to start getting mindful about your sugar intake in your 20’s for many different reasons. “Sugars and carbohydrates are a beauty killer because they are proinflammatory. Pasta, ketchup, candy, ice cream, and fruit juices are often dietary staples for those under 30. Any inflammation in the body will show up on the face in the form of adult acne, sagging and wrinkling not to mention sallow skin tone,” warns Dr. Shah.
- Maintain your glow with facials and peels.
While many millennials are starting off with “Baby Botox” which can postpone wrinkling, Botox isn’t cheap. It also can be a “gateway” treatment which leads to lip injections and fillers that oftentimes have a reverse effect making younger women appear older, cautions Dr. Shah. “Lasers and peels have come very far, offer and excellent solution for sun damage, skin texture, pores, acne scarring and cell turnover to stimulate collagen growth. These treatments are still a bit costly for millennials, many of whom are on a strict budget,” he adds.
Dr. Shah concludes that millennials who get into a good solid habit of taking care of themselves both inside and out, will create a lifestyle of longevity. “Millennials raised by mothers who may have had breast implants, Botox, lip injections feel that getting things “done” is normal. This is exactly why I am always very honest when advising patients under 25 on procedures they’re considering.”
About Dr. Manish Shah
Plastic Surgeon Colorado | Dr. Manish Shah, M.D. | Denver https://drmanishshah.com/
Manish Shah, M.D., F.A.C.S. is board-certified by the American Board of Plastic Surgery and member of the American Society of Plastic Surgeons, the American Society of Aesthetic Plastic Surgery and the International Society of Aesthetic Plastic Surgery. After completing his formal plastic surgery training in Plastic and Reconstructive Surgery at the Univ. of Tennessee College of Medicine, he moved to New York City and was selected for the prestigious Aesthetic Surgery Fellowship at Manhattan Eye, Ear, and Throat Hospital. He underwent extensive, advanced training in aesthetic surgery of the face, breasts, and body at the hands of some of the most renowned cosmetic surgeons in the world. Dr. Shah is one of only a select few plastic surgeons in the country who have undergone formal post-graduate training in aesthetic surgery.
Dr. Shah’s specialties include revision facial aesthetic surgery, rhinoplasty (“nose reshaping”), and aesthetic surgery of the breast (breast augmentation, breast lift, breast reduction). He is, however, well-trained in all areas of aesthetic surgery. Dr. Shah’s aim is to obtain a natural appearing transformation that complements the real you!
Page 1 Solutions Acquires Strategic Edge Partners
Aesthetic marketing industry icon Dana Fox named vice president of practice development at Page 1 Solutions
LAKEWOOD, Colo. – Sept. 28, 2018 – Premier digital marketing agency Page 1 Solutions announced on Friday that it has acquired Strategic Edge Partners, a marketing agency providing online, print, and on-site services to plastic surgeons, aesthetic and dermatology practices, med spas, and industry suppliers. Dana Fox, president and CEO of Strategic Edge Partners, has joined Page 1 Solutions as vice president of practice development.
For more than 30 years, Fox has been a leading voice and source of marketing expertise for aesthetic practices and suppliers who want to expand their business and drive revenue. Strategic Edge Partners has served clients throughout North America for 11 years.
“With her experience and the broad range of marketing services she offers, Dana Fox will bring a lot of value to Page 1 Solutions and our clients,” said Dan Goldstein, president and owner of Page 1 Solutions. “I’ve had the pleasure of knowing Dana for years. I’ve always admired her reputation and knowledge. I’m very excited to inform our clients that she is part of the Page 1 family, and that we can now offer an even broader range of services.”
Page 1 Solutions has provided digital marketing services for plastic surgeons for over 15 years, including search engine optimization (SEO), website design and development, social media marketing, reviews and ratings management, and more. With the acquisition of Strategic Edge Partners, the agency will begin offering additional services such as:
- Patient loyalty programs
- On-site practice consulting
- Print and collateral promotional material
- Advertising
- Electronic procedure guides
- Event planning
Strategic Edge Partners and Page 1 Solutions share common core values. Their joint commitment to serving the aesthetic industry with integrity while growing each practice’s bottom line will create new opportunities for clients of both agencies.
“What strikes a chord with me is the way Dan and his company care about the clients,” Fox said. “That’s exactly how I feel about my clients, and together I believe we can achieve a new level of results. I am also delighted that Strategic Edge clients now have the additional opportunity, through Page 1’s proven expertise, to greatly increase lead generation and conversion.”
Fox is regularly featured as a speaker on marketing and branding at medical aesthetics industry events hosted by the American Society of Plastic Surgeons, the American Society for Aesthetic Plastic Surgery, the American Academy of Cosmetic Surgery, and others. Another frequent presenter at many of these events is Bill Fukui, vice president of sales and marketing at Page 1 Solutions.
“Whenever Dana and I cross paths at these events, I’ve always been impressed by the experience and insights she shares,” Fukui said. “She has clearly earned the respect of doctors, surgeons, and practice managers in the industry. She will be a tremendous asset for our clients and the entire Page 1 team.”
Both Page 1 Solutions and Strategic Edge Partners make client success a priority. In light of the acquisition, the focus on results is consistent online and offline, empowering one agency to offer a continuum of solutions that encompasses digital marketing, practice management, conversion of new patients and customers, and activation of current patients.
About Page 1 Solutions, LLC
Founded in 2001, Page 1 Solutions is a full-service digital marketing agency. The agency serves plastic surgeons, dermatologists, and other practices in the medical aesthetics industry, as well as attorneys, dentists, and ophthalmologists throughout North America. In 2018, Page 1 Solutions acquired Strategic Edge Partners, a boutique company specializing in cosmetic practice branding, event planning and on-site strategy, and loyalty programs. Now, Page 1 Solutions is a multi-channel and multimedia marketing agency, with services ranging from search engine optimization and website design to creation of print collateral and in-person practice consulting.
Facebook: https://www.facebook.com/page1solutions
Twitter: https://twitter.com/page1solutions
YouTube: https://www.youtube.com/user/page1solutions
LinkedIn: https://www.linkedin.com/company/page-1-solutions
Pinterest: https://www.pinterest.com/page1solutions/
Google+: https://plus.google.com/+Page1solutions
About Strategic Edge Partners
Strategic Edge Partners provides personalized services to plastic surgery offices and aesthetic medicine practices. Team members at Strategic Edge help cosmetic surgeons, doctors, med spa directors, and industry suppliers build distinct brand identities that set them apart from competitors. Strategic Edge Partners provides on-site consulting, production of print ads and collateral, launch and support for customized loyalty programs, and other marketing strategies.
Website: https://yourstrategicedge.com/
Arthritis Research Public Forum Returns for 13th Year
Top Scientists to Reveal Latest in Arthritis Prevention and Treatment at ROAR 2018
VANCOUVER, Sept. 27, 2018 /CNW/ - Leading research scientists will present the latest in arthritis prevention and treatment at Arthritis Research Canada's annual Reaching Out with Arthritis Research public forum on September 29.
The event is hosted by the patient advisory board of Arthritis Research Canada – the largest clinical arthritis research centre in North America – and includes six presentations, a panel discussion and a live-webinar for those who can't attend in-person.
"Reaching Out with Arthritis Research bridges the gap between research and the real world," said Dr. John Esdaile, Arthritis Research Canada's scientific director. "It's an opportunity for the public to find out how research leads to prevention and life-changing treatments."
This year's presentations will cover everything from how to prevent arthritis to medication safety during pregnancy to joint replacement surgery advice to basic and cutting-edge assistive devices and activity modifications to the importance of arthritis research and more.
"We are the first organization in the world to conduct studies on the safety of arthritis medication use during pregnancy," Dr. Esdaile said. "And this is just one example of what people can learn about at ROAR. We're always pushing the boundaries to improve quality of life for those living with arthritis."
Reaching Out with Arthritis Research 2018 will take place at the Ismaili Centre of Burnaby (4010 Canada Way) on September 29th from 9:30am to 12:30pm.
To register for the in-person event or the live webcast: https://conta.cc/2MLl7U2
ABOUT REACHING OUT WITH ARTHRITIS RESEARCH (ROAR)
Reaching out with Arthritis Research is a public forum hosted by the patient advisory board of Arthritis Research Canada. Every year, top scientists and medical professionals present on various topics related to arthritis research. The event includes a panel discussion where members of the audience are encouraged to ask presenters questions.
ROAR 2018 Media Kit: http://www.arthritisresearch.ca/wp-content/uploads/2016/04/ROAR-2018-Media-Kit.pdf
More information about ROAR 2018: http://www.arthritisresearch.ca/roar
Register for ROAR 2018: https://conta.cc/2MLl7U2 or call or call 1.844-207.0400
View ROAR 2017 panel discussion: https://www.youtube.com/watch?v=GRWwWpG9H6c
ABOUT ARTHRITIS RESEARCH CANADA
Arthritis Research Canada is the largest clinical arthritis research centre in North America. Our mission is to transform the lives of people living with arthritis through research and engagement. Led by world-renowned rheumatologist, Dr. John Esdaile, Arthritis Research Canada's scientific team of over 100 are creating a future where people living with arthritis are empowered to triumph over pain and disability. With centres in British Columbia, Alberta and Quebec, Arthritis Research Canada is leading research aimed at arthritis prevention, early diagnosis and treatment, and quality of life issues.
SOURCE Arthritis Research Canada
FDA Programs under further scrutiny as new JAMA study criticizes the breakthrough therapy designation, observes GlobalData
The FDA’s Breakthrough Therapy Designation (BTD) recently came under fire in a study published in JAMA in July by three researchers at Yale. The authors maintain that contrary to the beliefs of stakeholders, including physicians and the general public, some of the pivotal trials used to support the BTD were missing elements of a rigorous study design such as randomization, proper controls, double-blinding, the use of surrogate endpoints, as well as large enough numbers of enrolled patients.
BTD can be assigned if preliminary clinical evidence suggests an advantage over existing options. Since the program was initiated in 2012, 114 BTD approvals for 77 different drugs have been granted across all therapeutic areas.
However GlobalData, a leading data analytics company, believe that given the types of advanced indications with high unmet need, in which developers tend to seek BTD, it is not surprising that so called less-rigorous studies are the standard.
Fern Barkalow, PhD, GlobalData Healthcare Oncology and Hematology Director commented, “Requiring parameters for approval that are not very feasible to achieve within the population of patients with advanced diseases, those that are without other reasonable treatment options, would not be a step in the right direction.’’
The FDA’s accelerated approval designation, allows for submissions based on the use of surrogate endpoints, with the intent that the initial approval would be followed up by a regular approval, based on the successful completion of more robust endpoints in post-market studies.
Barkalow continued, ‘‘As an example, for most cancer indications, progression-free survival (PFS) is used as a surrogate endpoint for initial approvals, especially because it is quicker to measure than a clinical endpoint such as overall survival (OS), and it has since been validated as a fairly good surrogate endpoint for many cancer types in a variety of studies.”
FDA guidance issued in 2007 titled, ‘Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics’ recommended that PFS be used only in the context of randomized studies, which is not always possible or ethical in the case of advanced cancers and late-stage diseases in other therapeutic areas. One of the criticisms of the FDA’s BTD program mentioned in the JAMA article refers to the use of surrogate endpoints, yet the evidence is mounting that not only is PFS a valid surrogate endpoint, but it is now acceptable for regular approval in at least one oncology indication.
Barkalow concluded, ‘‘Given the nature of certain advanced forms of disease and the few available options and time left for patients with these diseases, it may be more productive to view the criticisms of the FDA’s BTD program highlighted in the recent JAMA article partly as an issue of semantics, and a re-examination of the definition of scientific rigor in this context would be a reasonable next step.’’
