An amazing group of people came together for Climb to Defeat ALS earlier this month. The first Team Challenge ALS team summited Mt. Elbert in Colorado on September 7 and has raised over $65,000 for The ALS Association, so far.
We asked a few team members to tell us about their experiences.
Continue reading Team Challenge ALS Climbs to Defeat ALS
The ALS community recently presented its recommendations to the U.S. Food and Drug Administration (FDA) regarding the Amyotrophic Lateral Sclerosis: Developing Drugs for Treatment Guidance for Industry at a day-long event, called ALS Community Workshop: Therapy Development and Regulatory Pathways, which was held in Washington, D.C., on July 12. Over 90 people attended in person, with many more tuning in online.
Throughout the day, there were opportunities to make comments to the FDA and industry representatives, both in-person and online. The Association was proud to host the day to bring many ALS stakeholders together to provide targeted feedback and information to further inform the FDA’s Draft Guidance on ALS Drug Development.
The FDA’s Draft Guidance provides drug developers with recommendations for all aspects of clinical trials for ALS, from study design to risk-benefit considerations to patient selection. For many years, The ALS Association has worked closely with the FDA and members of the ALS community in the development of a comprehensive ALS Guidance to make clinical trials faster, shorter, and more responsive to special considerations inherent to people with ALS and their caregivers.
The Workshop was an opportunity to provide targeted feedback and information from the ALS community to further inform the FDA’s Draft Guidance on ALS Drug Development. After the Workshop, the Association composed a report to the FDA to address key points discussed at the Workshop and to make recommendations on how to improve the FDA’s final Guidance (listed below).
“The purpose today is to build a strong guidance together,” said Calaneet Balas, president and CEO of The ALS Association. “We will be taking the great ideas from this meeting and presenting them to the FDA for their consideration in developing the final Guidance document. We look forward to that document, and to seeing it used widely for making clinical trials faster, more effective, and more aligned with the needs of patients and caregivers. We believe that is the route to the fastest development of new treatments for ALS.”
Continue reading Members of ALS Community Gather with Representatives from FDA and Industry to Inform FDA Draft Guidance on ALS
“When someone you love becomes a memory…that memory becomes a treasure,” said Christine Caron, a participant in the Western Massachusetts Walk to Defeat ALS.
Each year, tens of thousands of people come together at Walk to Defeat ALS® events across the country with one common goal: to remember treasured loved ones and honor those who are fighting ALS every day.
The ALS Association launched Unlock ALS at Walk events this fall to provide participants with a tangible way to recognize the real reasons we Walk to Defeat ALS. At each Walk event, participants select a lanyard in one of four colors to represent their connection to ALS, receive a branded key, and join in a meaningful opening ceremony.
“Seeing all the different colored lanyards made me feel like we were one big family as we’re all going through this together,” said Roxane Baillargeon, a Western Massachusetts Walk participant who is living with ALS.
Continue reading Unlock ALS Honors the Real Reasons We Walk to Defeat ALS
By Mary Johnson, Caregiver – Western Pennsylvania
Note: Under current law, people disabled with ALS who qualify for Social Security Disability Insurance (SSDI) must wait five months before receiving SSDI benefits. Every person must wait, regardless of the level of disability or how fast the Social Security Administration (SSA) approves their claim.
The ALS Disability Insurance Access Act (S.379/H.R.1171) would eliminate that five-month waiting period for people with ALS to receive SSDI. People with ALS would receive their SSDI benefits immediately after being approved by the SSA.
The five-month waiting period for Social Security Disability Insurance (SSDI) after an ALS diagnosis has severely impacted my family and I’m mad as hell about it. There’s absolutely no reason people with ALS shouldn’t be getting both SSDI and Medicare benefits immediately.
I can tell you from my own experience – we don’t have five months to wait.
My family has the genetic form of ALS (familial ALS). As of June 2018, I’ve lost 14 family members — siblings, aunts and uncles, nieces and nephews, and cousins – to this horrific disease.
My 25-year-old niece, Amanda, died four months after her ALS diagnosis – before the SSDI waiting period was met. The same situation occurred for my niece, Shannon, who died at age 34. She was diagnosed in January 2013 and died just two months later.
Continue reading Guest Post: We Don’t Have Five Months to Wait
Yesterday, ITF Pharma, Inc. announced that Tiglutik™, the first and only thickened liquid form of riluzole, was approved by the FDA for the treatment of ALS. This formulation contrasts with the oral pill form of riluzole that has been on the market for ALS for more than 20 years.
This thickened liquid form of riluzole should help individuals with swallowing difficulties. Approximately, 80 percent of people with ALS develop difficulty swallowing because of gradual weakness and paralysis in the muscles of the face and throat, called bulbar muscles.
In ALS, muscle weakness in the face and throat can lead to swallowing issues called dysphagia, along with problems with chewing, salivation, talking, and drinking. This often results in unwanted weight loss, issues taking oral medications, and in some cases, choking and aspiration, which is when food or liquid go down the wrong tube and into the lungs.
To counteract difficulties swallowing, many people with ALS end up crushing their pills. When medication is not taken as prescribed, its effect may decrease. Tiglutik provides an alternative as a thickened liquid, which can be administered orally twice-daily via a syringe. Its most common side effects are in line with established side effects observed in oral riluzole.
Continue reading Tiglutik – Thickened Liquid Riluzole – Receives FDA Approval to Treat ALS
In New Video, People With ALS Talk About Losing Jobs to the Disease
This weekend, people across the country will pause to reflect on and celebrate the economic and social value of American workers. And on Monday, many of them will enjoy a paid holiday off from work.
As we light the grills to enjoy a long Labor Day weekend and enjoy a break from some of the doldrums of work – the long commutes, the looming deadlines, and the stress and monotony – there are many people who want to work but are unable to do so.
One of the first things ALS often takes away is a person’s ability earn a living. In this new video, people living with ALS, along with their caregivers and friends, talk about the impact ALS has on the ability to work.
Please watch and share this video with your friends and family and encourage them to join the fight for a world without ALS.
Continue reading ALS Takes Away a Person’s Livelihood
Our Every Drop Adds Up campaign builds on the idea that people coming together for a common goal can make the impossible happen, just as it did four summers ago when the ALS Ice Bucket Challenge soaked the world. Every person helped, research project funded, story shared, discovery made, dollar raised, piece of legislation passed, mile walked, and auction bid placed – it all adds up!
Noel LeVasseur thought he was dealing with the aches and pains that come after years of holding down a physically demanding job – maybe carpal tunnel or arthritis.
“Then finally we got the diagnosis that our world was going to change quickly,” he said.
In November 2017, Noel was diagnosed with ALS.
Noel said the diagnosis wasn’t a “woe is me” moment because he and his family sensed what was happening. Instead, he said, it was time to move to the next stage in life and come up with a new plan.
Noel married his wife, Jen, just two years ago. He’s the father of two daughters, Morgan and Madison, and the stepfather of Jen’s two sons. He likens his blended family as one boy and one girl away from the Brady Bunch.
Noel talked to us about the new life plan – about the bad and the good days, the challenge of brushing his teeth some mornings, and the beer fests, concerts, and ballgames in his future.
Watch this video featuring Noel and Jen then share their story with your friends and family to help raise awareness of ALS. Continue reading Noel LeVasseur: ‘I’m Here to Do Good For This’