The video game, called EndeavorRx and approved on Monday, will be prescription only and aimed at children between the ages of eight and 12 with certain types of ADHD.
It will be used alongside other treatments, such as clinician-directed therapy, medication and educational programs.
ADHD is a common neurodevelopmental disorder which is usually first diagnosed in children and can last into adulthood.
Approximately 4 million children aged six to 11 are affected by ADHD, the symptoms of which include difficulty staying focused and paying attention and difficulty controlling behavior.
This is the first game-based therapy to be granted marketing authorization by the FDA for any condition, the agency said.
“The EndeavorRx device offers a non-drug option for improving symptoms associated with ADHD in children and is an important example of the growing field of digital therapy and digital therapeutics,” Dr Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a press release.
The game, which can be downloaded as an app onto a mobile device, was authorized for marketing after the FDA reviewed five clinical studies that included more than 600 children.
The agency noted that some negative effects were reported, such as frustration, headache, dizziness, emotional reaction and aggression, but said there were no “serious” adverse effects reported.
While playing the game, children steer an avatar through a course dotted with obstacles, collecting targets to earn rewards.
Akili, the company that created EndeavorRx, has said that children should interact with the game 30 minutes per day, five days a week over the course of a one-month treatment cycle.
Continue on to KTLA News to read the complete article.
It began in 2011. Selma Blair didn’t know where it all came from—the overwhelming fatigue, anxiety, depression, neck pain, and severe vertigo.
She didn’t understand why that after she’d drop her son, Arthur, off at school, she was so exhausted that she had to get back into bed. She was puzzled by the sudden loss of feeling in her leg.
Selma would go to doctors seeking answers, but they dismissed her symptoms, believing her exhaustion and fatigue were the result of her becoming a new mother. As the constant pain continued, Selma began to self-medicate to dull the pain.
“When I first suspected that something wasn’t right with my health, with my brain, was when I was pregnant with Arthur,” Selma shared with DIVERSEability Magazine. “I really knew something was wrong when I ran into a UPS truck…literally. I mean, I just skimmed it, but I realized my perception was really off. That’s when I went to the eye doctor thinking it was just my eyes, but it was a perception coordination thing. I’d felt exhausted for years, but it really reached a point that I couldn’t deny it when I was first pregnant with Arthur, and certainly right after his birth.”
It wasn’t until 2018, when she was filming the movie After, that Selma finally got answers.
“When I was in Atlanta the first time shooting the beginning of the film, I had extreme vertigo on steps; I was walking with Josephine Langford down some steps, and I was like, ‘whoa, something’s really happening.’ I couldn’t feel my left leg or my right side and was having difficulty writing and texting, so I sent my manager a video telling him that something very strange is going on.”
Selma heeded the advice from a new doctor who urged her to get an MRI, during which she was in tears, frightened of what was happening to her body.
The results were undeniable: 20 lesions on her brain—it was multiple sclerosis.
“I cried. I had tears. They weren’t tears of panic—they were tears of knowing I now had to give in to a body that had loss of control,” she said in an interview with Good Morning America’s Robin Roberts. “There was some relief in that, ’cause ever since my son was born, I was in an M.S. flare-up and didn’t know. I was giving it everything to seem normal.”
The Journey with M.S.
Multiple sclerosis, or M.S., is a potentially disabling disease. It impacts the brain and central nervous system. It gradually affects the entire body. It causes the immune system to eat away at the protective covering of the nerves.
Having M.S. is an emotional, painful, and unpredictable ride, sometimes leaving people who suffer from the disease wanting to give up.
But, for Selma, that is not the case. “There’s no tragedy for me,” she told Vanity Fair. “I’m happy, and if I can help anyone be more comfortable in their skin, it’s more than I’ve ever done before.”
The 48-year-old actress is resilient, using M.S. as a way to fight, giving hope to others suffering from the disease, and being an advocate for people with disabilities.
Through her journey with M.S., Selma decided that she would open about her disease and not hold anything back from the press or social media. “This is my journey…and all are welcome here,” she writes on her Instagram page.
“It just made sense to be candid. At the time, I was in a long flare and was very symptomatic. It was all new to me, and I just didn’t want to bother playing any type of game of peekaboo,” she said.
This candidness is evidenced through her interviews, such as her appearance on Good Morning America, in which she appeared with a cane and her statement of wanting to make canes chic, which touched many viewers who witnessed the interview, many of whom have their own canes.
Selma rocks her cane, viewing it as a great fashion accessory. When she first stepped out with a cane at the 2019 Vanity Fair Oscar Party in Beverly Hills, Selma turned heads, and prompted others to show the same courage. Twitter feeds were filled with praise for the star:
“The real winner of Oscar night is Selma Blair.”
“#SelmaBlair in tears as she attends the @VanityFair #Oscars party made me cry. I’ve often been walking on aid and exhaustion can just hit and you think, how am I going to do this? But you keep going. She is amazing.”
Selma was—an is—an icon.
Advocating and Raising Awareness
Selma aims to bear all and to help raise awareness for those suffering from this little understood disease and those who, like Selma years ago, have no idea they have M.S.
Selma shared her insights into the struggles that impact her not just as a woman but also as a single mother.
“One of the bigger things is honestly the fatigue. As a mom or anyone trying to do something primarily by themselves with a little tiny person witnessing everything you’re doing, it can feel unsustainable. Figuring out intricacies of neurological disorders is a constant reckoning of how to do better, when to sleep, what you can do, what is very emotionally triggering, you know. There are many layers of it that I now see, people with the disabilities are so busy in our minds.”
Through the sharing of her journey, Selma makes it her mission to help those struggling with M.S. and other disabilities. She credits others who have taken this path of openness and advocacy, such as Michael J. Fox, with inspiring her to do the same.
“I remember when I was younger and Michael J. Fox came out. I was
such a humongous fan of his, and seeing him be so candid about something that seemed so far away from me at the time. I’ve kind of held his example, and I’ve learned that there is an intrinsic value in opening up some of your experiences to people, because the conditions we deal with are often very isolating and when there’s someone that’s out there that could possibly really shed a light on it and bring more attention.”
Her grace and humility as well as her willingness to be a light shining into the unknown darkness for people with disabilities is heroic, though she shrugs off such a label.
“I’m not a hero. I make no bones about that in my life. But I am very honored if my experience, my mess ups and my triumphs help other people,” she said.
For those who are struggling with the disease or for those who have recently been diagnosed, Selma offers some insight and advice:
“Some people said you’ll be better right away. Some said no, healing is not linear. It can take two years. I kind of have fallen in between all that, and I think I would tell someone, ‘Your whole mind can change. Try not to be afraid. I’ve learned so many things, and I pray that you continue to search for what can make you happy and calm. But it takes time. I’m just starting to feel like I’m learning now.’”
To 9-year-old Arthur, his mom is a hero, and he does not view her experiences negatively. “He says, ‘Mommy’s not sick. Mommy’s brave,’” Selma shared with People.
Selma’s commitment to Arthur has remained steadfast and honest. He has seen her face these challenges but remains extremely proud of his resilient mother.
She stated, “He said, ‘I love when you come to school because you make the kids laugh and you answer all their questions.” She remains completely open about her struggles, even with Arthur’s classmates, explaining to them why she may walk differently.
“I explain what’s happening and that my voice doesn’t hurt, and we have really decent exchanges. I had no idea Arthur was proud of that. I thought ‘I’m probably an embarrassment,’ but to know I’m not was one of my proudest moments.”
Selma’s resilience started at a young age. She was born outside of Detroit, Michigan, in the suburb of Southfield. Her interest in acting took hold at an early age, and she credits a high school English teacher, Mr. Toner, with pushing her forward, telling her never to give up, which would serve her well in years to come.
Moving to New York, she was torn between acting and photography.
“When I went to New York, the purpose was a toss-up,” Selma stated. “I didn’t know if I could be a photographer or an actress, but with acting, you can at least go to a class and do workshops, but it was hard to just be an assistant for someone without a lot of experience as a photographer and break-in, so they were both passions.”
Over the years, Selma has played many roles with more than four dozen short and feature films. Her most favorite role was her first major picture, the 1999 film Cruel Intentions with Selma starring opposite actors Ryan Phillippe, Sarah Michelle Gellar, and Reese Witherspoon.
“It was kind of the dream come true first job. After studying in New York, I went to LA, and my first major part was in a real studio film. And while I had done a few small roles before that, that was really my first substantial role with stars that I had loved and they were basically my contemporaries, but, of course, they are already established actors. I laughed and laughed and laughed, and that’s when I kind of realized I really loved what comedy could be and how it could feel.”
Shining Light, Bringing Hope
Selma’s journey is one of inclusion, a journey that many have been on and, sadly, many more are just beginning. Through her candidness, she is willing to share her triumphs and defeats with the world to help others learn, to be a pathfinder for those suffering from the debilitating symptoms of multiple sclerosis. She is a hero of advocacy.
And through it all—her slurred speech, aches and pains, exhaustion, and much more—Selma handles it all with a smile, even amid the COVID-19 pandemic. “…Take this opportunity to be the best you can be, to help your days along,” she said.
For Selma, there is no tragedy—only positivity. “I don’t know if I believed in myself or had the ambition before my diagnosis,” she said to Vanity Fair. “And oddly now I do, and I don’t know if it’s too late.”
Breast cancer awareness month or National Breast Cancer Awareness Month begins on Thursday, October 1 and ends on Saturday, October 31 2020.
After skin cancer, breast cancer is the most common cancer in women, with an average lifetime risk of developing breast cancer at 12 percent. There are about 300,000 cases diagnosed each year, with about 15 percent of those (40,000 people) dying from the disease each year.
A clearer way of looking at it and why it’s so serious is that 1 in 8 women will have breast cancer, and 1 woman is diagnosed with breast cancer every two minutes. Additionally, and contrary to what most people believe, breast cancer doesn’t just end with the female folks, men can develop breast cancer as well (although its rare).
Always keep in mind that screening for breast cancer begins at 40 years old (for average risk women) with annual mammograms, and that catching breast cancer early can save your life.
Why Go Pink for October?
Every October, the color pink shows up in full force. From lapel pins to NFL uniforms, people integrate pink into their wardrobes to support breast cancer awareness month. As an awareness campaign, it’s incredibly successful. But awareness is just the first step. From awareness, public health education and advances in research are possible.
Lydia Komarnicky, MD, professor and chair of the Department of Radiation Oncology and a member of the board of the Susan G. Komen Foundation, says wearing pink “reminds people of the importance of the month of October and to get a mammogram if you have forgotten. More importantly, I think the pink shirt, ribbon, hat, or merchandise of your choice honors those who have successfully beaten the disease, those who are currently battling the disease, and also reminds us of those that have succumbed to the disease.”
History Behind the Pink Ribbon or Breast Cancer Awareness
Charlotte Hayey, who had battled breast cancer, introduced the concept of a peach-colored breast cancer awareness ribbon. In the early 1990s, 68-year-old Haley began making peach ribbons by hand in her home. Her daughter, sister and grandmother had breast cancer. She distributed thousands of ribbons at supermarkets with cards that read: “The National Cancer Institute annual budget is $1.8 billion, only 5 percent goes for cancer prevention. Help us wake up our legislators and America by wearing this ribbon.”
Statistics You Should Know
• About 1 in 8 U.S. women (about 12 percent) will develop invasive breast cancer over the course of her lifetime.
• In 2020, an estimated 276,480 new cases of invasive breast cancer are expected to be diagnosed in women in the US, along with 48,530 new cases of non-invasive (in situ) breast cancer.
• About 2,620 new cases of invasive breast cancer are expected to be diagnosed in men in 2020. A man’s lifetime risk of breast cancer is about 1 in 883.
• About 42,170 women in the US are expected to die in 2020 from breast cancer. Death rates have been steady in women under 50 since 2007 but have continued to drop in women over 50. The overall death rate from breast cancer decreased by 1.3 percent per year from 2013 to 2017. These decreases are thought to be the result of treatment advances and earlier detection through screening.
• For women in the US, breast cancer death rates are higher than those for any other cancer, besides lung cancer.
• As of January 2020, there are more than 3.5 million women with a history of breast cancer in the US. This includes women currently being treated and women who have finished treatment.
• Besides skin cancer, breast cancer is the most commonly diagnosed cancer among American women. In 2020, it’s estimated that about 30 percent of newly diagnosed cancers in women will be breast cancers.
• In women under 45, breast cancer is more common in Black women than white women. Overall, Black women are more likely to die of breast cancer. For Asian, Hispanic, and Native-American women, the risk of developing and dying from breast cancer is lower. Ashkenazi Jewish women have a higher risk of breast cancer because of a higher rate of BRCA mutations.
• Breast cancer incidence rates in the US began decreasing in the year 2000, after increasing for the previous two decades. They dropped by 7 percent from 2002 to 2003 alone. One theory is that this decrease was partially due to the reduced use of hormone replacement therapy (HRT) by women after the results of a large study called the Women’s Health Initiative were published in 2002. These results suggested a connection between HRT and increased breast cancer risk. In recent years, incidence rates have increased slightly by 0.3 percent per year.
• A woman’s risk of breast cancer nearly doubles if she has a first-degree relative (mother, sister, daughter) who has been diagnosed with breast cancer. Less than 15 percent of women who get breast cancer have a family member diagnosed with it.
• About 5–10 percent of breast cancers can be linked to known gene mutations inherited from one’s mother or father. Mutations in the BRCA1 and BRCA2 genes are the most common. On average, women with a BRCA1 mutation have up to a 72 percent lifetime risk of developing breast cancer. For women with a BRCA2 mutation, the risk is 69 percent. Breast cancer that is positive for the BRCA1 or BRCA2 mutations tends to develop more often in younger women. An increased ovarian cancer risk is also associated with these genetic mutations. In men, BRCA2 mutations are associated with a lifetime breast cancer risk of about 6.8 percent; BRCA1 mutations are a less frequent cause of breast cancer in men.
• About 85 percent of breast cancers occur in women who have no family history of breast cancer. These occur due to genetic mutations that happen as a result of the aging process and life in general, rather than inherited mutations.
• The most significant risk factors for breast cancer are sex (being a woman) and age (growing older).
Horses are not only “good for the inside of a man,” but uniquely suited for mental health therapy for veterans due to both instinct and behavior. When paired with a human, a horse will intuitively react to behavioral patterns or body language from the human.
This gives insight into how a person is being perceived. Because they are prey animals, horses are constantly on the lookout for danger and respond quickly with either confrontation or flight. This instinct allows for a deeper level of intervention with a therapist that surpasses any other mental health treatment.
StableStrides is a 501(c)(3) nonprofit whose primary focus is mental health therapy with horses. Situated in the large military community of Colorado Springs, CO, StableStrides is uniquely positioned to serve veterans, active duty servicemembers and military families. On a mission to significantly improve the lives of people through a connection with horses, StableStrides exists because of horses and their ability to touch the lives of people.
Horses and humans share a history that goes back to ancient times and has continued to today. Their role in medicine was first prescribed by Hippocrates (460 BC-375 BC) as a form of natural movement that strengthened the body. Hippocrates, the “Father of Medicine,” believed in health that united body and mind and studied treatment for trauma and mental healthcare. Since then, relationships between horse and human has been studied and incorporated into modern medical practices, both physical and mental.
The physical aspects of horseback riding are used to develop physical strength, muscle development and other physical benefits, while the relationship between horse and human is known to strengthen both mind and spirit. Today, the term Equine Assisted Activities and Therapies (EAAT) defines the use of the horse in recreational and medical intervention. A large portion of EAAT is focused on veterans and their healing journeys during and after service. When partnered with a horse, a veteran is asking the horse to enter into a relationship with them that requires mutual trust and some degree of vulnerability.
One veteran reflects on his mental health sessions at StableStrides by asking:
“How could they go from resting and relaxed to full alert, with a first instinct to run, then to relax again, in seconds? How they could let go of that tension and anxiety and just “be?” As a herd animal, they entrust leadership to the strongest. That leader makes the decisions for the herd for as long as it’s capable or trusted. How can a prey animal, the horse, come to trust an apex predator, a human, with their safety? What a concept. This huge, powerful animal, easily capable of killing me, that fears me because I am a predator, could come to trust and work for me because it wants to.”
As prey animals, centuries of domestication have done little to lessen the horse’s response to danger. They understand that their best chance in escaping danger is to flee. As a result, the horse’s “fight-or-flight” instinct is used for decision making. In addition, horses are extremely perceptive and communicate with body language to convey fear, anger, calm or anxiety.
In a herd, each member relies on the leaders in the hierarchy to make decisions for the safety of the herd, if that leader can be trusted. When in the absence of a herd, the horse will determine if the human is to be trusted as the leader. If not, the horse will decide on his own what is safest.
Therapists have selected horses to incorporate into therapy due to these characteristics, including what many call “mirroring of emotions”. While horses aren’t mirrors, they will often reflect their leader’s emotions. If their leader senses danger and responds with fear, so will the horse. If the horse senses calm in their leader, the horse will likewise be calm, trusting their leader’s instinct. In mental health therapy, the therapist incorporates the horse and the relationship between veteran and horse for a dynamic and therapeutic environment. Through the horse’s reactivity, a veteran and therapist are able to examine and process behavioral reactions or emotional incongruencies. This requires the veteran to be present and mindful as to what is unfolding, and to be transparent about reactions.
Many organizations such as StableStrides exist for the horse-human connection and improve lives through EAAT. Through a connection with horses, mental health therapy strengthens families and individuals. Because of the horse’s unique qualities and instincts, incorporating horses into mental health allows for a therapeutic intervention that surpasses any other form of mental health therapy.
The outbreak of COVID-19 may be stressful—it can be difficult to cope with fear and anxiety, changing daily routines, and a general sense of uncertainty.
Although people respond to stressful situations in different ways, taking steps to care for yourself and your family can help you manage stress.
Stress during an infectious disease outbreak can include
Fear and worry about your own health and the health of your loved ones
Changes in sleep or eating patterns
Difficulty sleeping or concentrating
Worsening of chronic health problems
Increased use of alcohol, tobacco, or other drugs
Things You Can Do to Support Yourself
Take breaks from the news. Set aside periods of time each day during which you close your news and social media feeds and turn off the TV. Give yourself some time and space to think about and focus on other things.
Take care of your body. Take deep breaths, stretch, or meditate. Try to eat regular, well-balanced meals; get some physical activity every day; give yourself time to get a full night’s sleep; and avoid alcohol and drugs.
Make time to unwind. Try to engage in activities and hobbies you enjoy. Engaging in these activities offers an important outlet for pleasure, fun, and creativity.
Connect with others. Talk with people you trust about your concerns and how you are feeling. Digital tools can help keep you stay connected with friends, family, and neighbors when you aren’t able to see them in person.
Set goals and priorities. Decide what must get done today and what can wait. Priorities may shift to reflect changes in schedules and routines, and that is okay. Recognize what you have accomplished at the end of the day.
Focus on the facts. Sharing the facts about COVID-19 and understanding the actual risk to yourself and people you care about can make an outbreak less stressful.
Call your healthcare provider if stress gets in the way of your daily activities for several days in a row. Source: nimh.nih.gov
On the evening of May 25, near the end of Mental Health Awareness Month, rapper Waka Flocka tweeted that he was going to dedicate his life to suicide prevention and mental illness. This tweet likely stemmed from the reminder of his deceased brother’s upcoming birthday, which would happen less than a week later.
The rapper tweeted his support by saying, “I’m officially dedicating my life to suicide prevention and mental illness!!! Y’all not alone Waka Flocka Flame is with y’all now!!!!”
In 2017, Waka Flocka revealed in an interview with the show The Therapist that his younger brother committed suicide in 2013. In this interview, he stated that his brother, Coades, tried to call him before taking his life, leaving Waka Flocka to wonder what would have happened if he picked up the phone.
While the specifics of what the renowned rapper will do is unknown at the moment, Waka Flocka has made his goals clear, stating in a follow-up tweet that he has officially accepted his brother’s passing and believes he is now in a better place.
Waka Flocka stated, “You have no idea how it feel to wanna take your own life man…my little brother took his own life…This year I’m officially accepting the fact that he’s in a better place.”
Groups at high risk for the coronavirus have been a top priority of the World Health Organization (WHO) and the Centers for Disease Control and Prevention (CDC), as protocol calls to maintain focus on keeping populations such as the elderly, those with underlying medical conditions, and pregnant women safe. One group, however, that has seldom been addressed during the outbreak is that of disabled people, which the WHO is now bringing to light.
The organization at the forefront of the pandemic response discussed the risk faced by those with disabilities during a livestream on TikTok — where it aims to provide accurate information, resources and support for the community — on Thursday. Lindsay Lee, a disability expert at WHO, led the conversation and provided reasons — from lack of information to reliance on people and products for assistance — as to why those living with disabilities may be at greater risk of contracting the illness of COVID-19.
According to a guidance document — which will soon be available on WHO’s site and which was provided to Yahoo Lifestyle by Lee — the direct limits on the safety and health of people living with disabilities include barriers to implementing basic hygiene measures, difficulty in enacting social distancing and the need to touch things to obtain information from the environment or for physical support. Other considerations with serious implications also include access to both healthcare and public health information.
The National Council on Disability (NCD) tells Yahoo Lifestyle that the last is of utmost importance. “People with disabilities need equal access to critical COVID-19 updates and official communications,” says Neil Romano, Chairman of the National Council on Disability, “which means sign language interpreters, captioning, and plain language, and federal law requires it.”
A March 18 letter from the NCD addressed to Stephanie Grisham, White House Director of Communications, brought attention to the need of Taskforce interpreters at public briefings for the millions of people in the United States who are deaf or hard of hearing. The NCD didn’t immediately confirm if the White House provided a response.
In the meantime, WHO took to TikTok to inform people of the proper measures to take now if directly or indirectly impacted by disability, including making sure that a person’s assistive products are properly disinfected. “These include wheelchairs, walking canes, walkers, transfer boards, white canes, or any other product that is frequently handled and used in public spaces,” the WHO document reads.
However, basic protection measures become even more important for a disabled person, and those around them, if they require care and cannot navigate the healthcare system themselves. In that case, WHO recommends that everyone in a disabled person’s household, including trusted friends and family, is aware of any important and relevant information that might be needed if that person becomes ill.
Precautions must also be put in place in case a caregiver becomes sick. “Consider increasing the pool of those you can call upon, in preparation of one or more becoming unwell or needing to self-isolate,” the WHO document states. “If you organize caregivers through an agency, find out what contingency measures they have in place to compensate for a potential workforce shortage.”
Shannon McCracken, vice president of government relations for ANCOR, the leading nonprofit trade association representing providers of services to people with disabilities, explains to Yahoo Lifestyle that some precautions are specific to certain groups, which ultimately impacts how vulnerable each individual really is to the illness. However, all people with disabilities are united through the greater efforts that must be made to maintain their health.
Continue on toYahoo News to read the complete article.
A pair of researchers from the University of Louisiana at Lafayette have developed an artificial intelligence system that predicts epileptic seizures with 99.6 percent accuracy.
The World Health Organization estimates that between 4 and 10 in every 1,000 people suffer from epilepsy-related seizures. According to numerous studies, 70 percent of those afflicted have symptoms that can be mitigated with medication. The problem is that many patients are unable to tell when they enter the preictal stage (the period directly before a seizure occurs) when such intervention would be effective.
Professor Magdy Bayoumi and researcher Hisham Daoud, the duo who created the system at University of Louisiana at Lafayette, want to take the guesswork out of seizure prediction. According to the pair’s research paper:
We propose four deep learning based models for the purpose of early and accurate seizure prediction taking into account the real-time operation. The seizure prediction problem is formulated as a classification task between interictal and preictal brain states, in which a true alarm is considered when the preictal state is detected within the predetermined preictal period.
Predicting a seizure is no small feat, especially for AI. Machine learning systems essentially run on data; the more you feed them the better the training and results. Unfortunately the frequency, detection time before onset, duration, and relative intensity of a seizure can vary wildly from one subject to the next.
This means, unlike teaching an AI to recognize photos of cats by feeding it millions of cat images, you can’t use a general purpose training dataset to create a seizure-detection system for individual patients. The researchers instead use long-term records of a person’s cranial EEG scans to develop a sort of baseline for brain activity before, during, and after seizures.
Patient’s personal data is required to develop the training and prediction paradigm, but the results are nothing short of astounding. Bayoumi and Daoud report near perfect accuracy at 99.6 percent detection with a false detection rate of nearly zero.
This has the potential to dynamically improve the lives of the estimated 50 million people afflicted with epilepsy world-wide.
The U.S. Food and Drug Administration (FDA) recently approved Trikafta (elexacaftor/ivacaftor/tezacaftor), the first triple combination therapy available to treat patients with the most common cystic fibrosis mutation. Trikafta is approved for patients 12 years and older with cystic fibrosis who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene, which is estimated to represent 90% of the cystic fibrosis population.
“At the FDA, we’re consistently looking for ways to help speed the development of new therapies for complex diseases, while maintaining our high standards of review. Today’s landmark approval is a testament to these efforts, making a novel treatment available to most cystic fibrosis patients, including adolescents, who previously had no options and giving others in the cystic fibrosis community access to an additional effective therapy,” said acting FDA Commissioner Ned Sharpless, M.D. “In the past few years, we have seen remarkable breakthroughs in therapies to treat cystic fibrosis and improve patients’ quality of life, yet many subgroups of cystic fibrosis patients did not have approved treatment options. That’s why we used all available programs, including Priority Review, Fast Track, Breakthrough Therapy, and orphan drug designation, to help advance today’s approval in the most efficient manner possible, while also adhering to our high standards. The FDA remains committed to advancing novel treatment options for areas of unmet patient need, particularly for diseases affecting children.”
Cystic fibrosis, a rare, progressive, life-threatening disease, results in the formation of thick mucus that builds up in the lungs, digestive tract, and other parts of the body. It leads to severe respiratory and digestive problems as well as other complications such as infections and diabetes. Cystic fibrosis is caused by a defective protein that results from mutations in the CFTR gene. While there are approximately 2,000 known mutations of the CFTR gene, the most common mutation is the F508del mutation.
Trikafta is a combination of three drugs that target the defective CFTR protein. It helps the protein made by the CFTR gene mutation function more effectively. Currently available therapies that target the defective protein are treatment options for some patients with cystic fibrosis, but many patients have mutations that are ineligible for treatment. Trikafta is the first approved treatment that is effective for cystic fibrosis patients 12 years and older with at least one F508del mutation, which affects 90% of the population with cystic fibrosis or roughly 27,000 people in the United States.
Continue on to the FDA to read the complete article.
When 18-year old Javier Larragoiti was told his father had been diagnosed with diabetes, the young man, who had just started studying chemical engineering at college in Mexico City, decided to dedicate his studies to finding a safe, sugar-alternative for his father.
“My dad tried to use stevia and sucralose, just hated the taste, and kept cheating on his diet,” Larragoiti told The Guardian. Stevia and sucralose are both popular sugar alternatives, and many reduced-sugar products available today contain one or the other.
With stevia and sucralose out of the picture, the young chemist needed to keep searching. He started dabbling with xylitol, a sweet-tasting alcohol found in birch wood but also in many fruits and vegetables. Xylitol is used in sugar-free products such as chewing gum and also in children’s medicine, but is toxic to dogs even in small amounts.
“It has so many good properties for human health, and the same flavor as sugar, but the problem was that producing it was so expensive,” said Larragoiti. “So I decided to start working on a cheaper process to make it accessible to everyone.”
Xylitol Made Cheaper
Corn is Mexico’s largest agricultural crop, and Javier has now patented a method of extracting xylitol from discarded corn cobs. Best of all, with 28 million metric tons of corn cobs generated every year in Mexico as waste, there’s no shortage of xylitol-generating fuel.
Simultaneously, Larragoiti hit on the idea of how to make xylitol less expensive, while inventing a way to reuse the 28 million tons of corn cobs, substantially upgrading the traditional means of disposal: burning them.
Especially in a pollution-heavy country like Mexico, reducing the amount of corn waste burned, would eliminate a portion of the carbon emissions.
His business, Xilinat, buys waste from 13 local farmers, producing 1 ton of the product each year. His invention was awarded a prestigious $310,000 Chivas Venture prize award, which will enable him to industrialize his operation and scale up production 10-fold, diverting another 10 tons of corn cob from the furnace.
Former NFL running back DeAngelo Williams has paid for over 500 mammograms for women—because, to him, the issue is personal.
He always wore the color pink in his hair, which flowed out from his helmet, during his later years as a player for the Carolina Panthers and Pittsburgh Steelers.
“Pink is not a color—it’s a culture to me.”
He created the DeAngelo Williams Foundation in honor of his mother, Sandra Hill, who died of breast cancer in 2006. All four of her sisters then died from the same disease—all before the age of 50.
He originally chose to pay for 53 mammograms because his mom died at age 53. He called the project #53StrongforSandra.” Since then, they have paid for 500 mammogram screenings for under-insured women in four states—North Carolina, Pennsylvania, Tennessee, and Arkansas, all states he has football ties in.