FDA Accelerated Approval of Genervon's GM604 for Use In ALS
My name is Nick and I am 54-years old. In October 2011, I was diagnosed with ALS. Today, I am in a wheelchair and cannot walk or stand. My arms grow weaker almost every day and my breathing is starting to be affected. I used to be very active but now I can only leave my home when I have someone with me who's strong enough to lift me into my wheelchair once I'm done scooting down to the bottom of the stairs on my butt. It can feel like I'm a 100-year old man who can't do things for himself anymore. At 54, I should still be a vibrant part of my community, but this disease is kicking me where it hurts. Through the enthusiasm generated by the Ice Bucket Challenge, many people now know that ALS is a degenerative neurological disease that currently affects over 30,000 Americans, and as it stands the disease is always fatal. Most people with ALS are given only 2-5 years to live. When I was diagnosed, I was devastated - it took me months to accept it. Although I am now resolved, I have not lost hope. Currently, there is only one drug available to treat ALS (Riluzole) and it is only able to extend life expectancy by a couple months. That's why the recent news about a small company named Genervon Biopharmaceuticals and their trial drug "GM604" has been so exciting for the Global ALS Community. While most trials have a hard time even finding a positive trend, the GM604 trial data supports the view that this drug could very well be is a game changer in the battle against ALS. There are multiple, statistically significant data. Not only in clinical data and results alone, but also correlated biomarkers data and results as well. (Please see "Files" section on the campaign website: https://sites.google.com/site/aap4gm6/) Genervon met with the FDA in February 2015 and made a potentially life-changing request on behalf of the ALS community; they asked the FDA to promote GM604 to the Accelerated Approval Program with Post-Marketing Phase 4 Requirements, so all ALS patients can have legal access to GM604 now. Under the FDA's Accelerated Approval Program, the treatments would be covered by health insurance. Although Genervon knows that this request might complicate their relationship with the FDA, they were willing to take a stand and do everything they can to help the ALS community because it is the right thing to do. If the FDA does not grant Accelerated Approval, it will likely be 3 more years before patients are able to access this drug -- meaning that most people currently living with ALS will not live to see it reach market. While acknowledging the paramount importance of public safety in the FDA’s drug approval process, I believe that ALS presents a compelling case for an exception to the usual process. I am asking you to help me appeal to the FDA through their sense of compassion for those of us with this dreadful illness. People with ALS don't have time to wait for another clinical trial to be completed. By signing this petition, you'll be helping patients like me request that the FDA expidite the way potentially life-saving treatments are made accessible to people with ALS -- starting right now with GM604. Doing so could very likely mean a change in the course of ALS progression not only for myself, but hundreds of thousands of other patients worldwide. After you sign, please follow this link to tweet and/or email the FDA: https://www.change.org/p/lisa-murkowski-fda-accelerated-approval-of-genervon-s-gm604-for-use-in-als/u/9475826 Thank you, Nick Like us on Facebook: https://www.facebook.com/gm604forals Please go to the Genervon website for a true understanding of the facts and the science behind GM604: http://www.genervon.com/genervon/about_pressreleases.php
Save Net Neutrality
Net neutrality preserves the right to communicate freely on the internet. Net neutrality requires internet service providers (ISPs) to give everyone equal access to everything you use on the internet-- email, watching videos, reading news articles, and listening to music. It prohibits ISPs from slowing down, speeding up, or blocking content on the internet. It is how the internet has always worked. Unfortunately, this is being threatened by the FCC- the Federal Communications Commission. If the FCC ends net neutrality, then how we’ve used the internet changes completely. ISPs will be able to block content, slow down internet access, and favor websites over others. It will also end the Title II of the Communications Act, which charges ISPs for blocking content or slowing down internet and creating “fast lanes.” “Fast lanes” would allow certain internet service providers to give internet access faster than any other service providers. Ending net neutrality could have global impacts and change the way the world shares information and changes how information is processed. As high school seniors about to enter into the real world, we cannot imagine what life would be like if we did not have net neutrality. Net neutrality allows us to use our freedom of speech on a platform that is like no other. I can go on the internet and research something without the fear that an ISP has favored a certain website that is completely biased one way or blocked certain websites. If you believe we should have free access to the internet, sign this petition to show your support. This issue is time sensitive and must be addressed. Support free and open internet! Thank you for your support, Katie Lemon
Make Election Day a Federal Holiday. Americans Deserve Time and Equal Opportunity to Vote.
We the people believe that voting is the heart and soul of democracy. Nearly 60% of voting-eligible Americans did not vote in the last midterm elections, citing work or school-related conflicts as the primary cause. Americans deserve time and equal opportunity to vote. Blue Point Brewing Company, along with other forward-thinking companies, has committed to giving our employees the day off to vote. But we need implement this change on a bigger scale. Join us in creating the change and protecting democracy. Convince Congress to establish Election Day as a Federal holiday. Blue Point Brewing Company is committed to this initiative and will be making Voters' Day Off beer cans available for supporters to sign and further inspire change.
Give the Vietnam Blue Water Navy Veterans their presumptive rights.
In 1977, the first claims of Agent Orange exposure came flooding into the Department of Veterans Affairs (VA). But it took 14 years for Congress to actually listen, take action and give our Vietnam veterans the benefits they deserved. The Agent Orange Act of 1991 was implemented to provide much-needed care to veterans who were exposed to the harmful chemical cocktail Agent Orange. Many of us thought the fight to get the medical attention we deserved was over, but that wasn’t the case. In 2002, the VA amended its initial plan and excluded thousands of “Blue Water” Navy vets -- vets who served right off the coast -- from receiving our rightful benefits. Because we hadn’t served on land, the VA tried to say we were unlikely to suffer the effects of Agent Orange poisoning. Even though we didn’t serve on Vietnamese soil, we were still exposed to Agent Orange. In fact, a 2011 study by the National Institute of Medicine found that Blue Water veterans could have been exposed in multiple ways, including via the ships’ water distillation system and through the air. The National Institute of Medicine also stated, “Given the available evidence, the committee recommends that members of the Blue Water Navy should not be excluded from the set of Vietnam-era veterans with presumed herbicide exposure.” We are asking for your help in urging Congress to pass legislation (House Bill H 299 and Senate Bill S 422) that will reinstate our right as Vietnam Navy veterans to receive the benefits we deserve for being exposed to this terrible chemical. Nearly 90,000 Blue Water vets are depending on you. We are dealing with serious health issues that range from cancer to diabetes, and from Parkinson’s to heart disease. Many of these diseases have made it nearly impossible for some of us to get steady work. Last year, the VA finally extended benefits to Air Force crew members who flew in C-123s after they had been used in Vietnam to spray the toxic cocktail. The VA came to the realization that even the slightest exposure to this chemical had serious effects on a soldier's health. So why are the Navy vets’ pleas being ignored? We breathed the Agent Orange-polluted air that drifted from the coast and drank water sprinkled with the herbicide, and now our bodies are paying the cost. We ask you to stand with us, and with Sen. Kirsten Gillibrand and Rep. David Valadao, and demand that the VA assume responsibility for the effects of Agent Orange on Blue Water vets. Please sign our petition asking Congress to pass House Bill HR 299 and Senate Bill S 422 and give us our benefits.