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
Tell the FDA to stop denying ALS patients treatment options
When I became a parent, I knew immediately that I would do anything to protect my daughters from the hardest parts of life. My mission would be to give them as much love and comfort as I possibly could. But now instead of me taking care of them, my daughters are often responsible for taking care of me, because in May of 2014 I was diagnosed with ALS. Now, instead of protecting them, my daughters are forced to watch as my body dies one muscle at a time. ALS is a devastating disease, that currently has no effective FDA approved treatments. However, there are promising therapies in the FDA approval pipeline that might improve my chances and quality of life, but the FDA isn’t willing to expedite the approval of these drugs, even though the average life expectancy of an ALS patient is 3-5 years and the average time it takes for a drug to become FDA approved is over a decade. Please join me and Hope NOW for ALS in petitioning Congress and the FDA to apply Accelerated Approvals (AAP) to promising treatments targeting terminal diseases, and implement faster, smarter, and more humane clinical trials using today’s science. This is not a radical or new idea. In 1992, in response to the HIV/AIDS epidemic, the FDA adopted the Accelerated Approval Program (AAP) – an expedited approval process to treat fatal diseases. This was a process to allow patients fast access to potentially life saving drugs, and has since been used for cancer and heart failure treatments. But the FDA refuses to apply it to ALS and other rapidly fatal diseases. How can it possibly be fair to exclude the most vulnerable and at risk people -- those with fast acting terminal diseases -- from this program? ALS is always fatal, and there are currently over 30,000 patients in the US with no options. We need help. We need options. My diagnosis is the greatest challenge my family has ever faced, and my daughters have amazed me with their grace and strength in taking on this battle with me. I know that even though my life has not turned out like I imagined it, I can still be the dad I always wanted to be, and I can still show my daughters what it means to take a stand for what counts. Please join me and Hope NOW for ALS to help save my life, and the lives of so many others around the country.
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
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.
Outlaw hog vs. dog hunting/fighting in the wild
Goal: To outlaw the cruel and inhumane practice of using dogs to hunt wild boar in Florida, as well as in the 31 others states it's currently legal or have no laws on the books. Florida (as well as other states) has a wild boar problem. Hogs are numerous, omnivorous and have no natural predators, making them one of the largest nuisance pests in the state. There are many humane options for dealing with the pigs, which do not need to involve brutally killing the pigs or putting domesticated dogs in harm’s way. However, despite the existence of alternatives, Florida and other states have exempted the use of "bait-dogs" in boar hunting. This practice is incredibly dangerous and very inhumane for the dogs and boars involved. Each of the 32 states that allow this practice laws differ, but Florida animal cruelty statute states: FLORIDA ANIMALS: CRUELTY; SALES; ANIMAL ENTERPRISE PROTECTION: http://www.leg.state.fl.us/statutes/index.cfm?App_mode=Display_Statute&Search_String=&URL=0800-0899/0828/Sections/0828.122.html 828.122 Fighting or baiting animals; offenses; penalties.—(1) This act may be cited as “The Animal Fighting Act.”(2) As used in this section, the term:(a) “Animal fighting” means fighting between roosters or other birds or between dogs, bears, or other animals.(b) “Baiting” means to attack with violence, to provoke, or to harass an animal with one or more animals for the purpose of training an animal for, or to cause an animal to engage in, fights with or among other animals. In addition, “baiting” means the use of live animals in the training of racing greyhounds.(c) “Person” means every natural person, firm, copartnership, association, or corporation.(3) Any person who knowingly commits any of the following acts commits a felony of the third degree, punishable as provided in s. 775.082, s. 775.083, or s. 775.084:Baiting, breeding, training, transporting, selling, owning, possessing, or using any wild or domestic animal for the purpose of animal fighting or baiting; (9) This section shall not apply to:.....(e) Any person using dogs to hunt wild hogs or to retrieve domestic hogs pursuant to customary hunting or agricultural practices." The exception (e) makes NO logical sense, because dogs are trained to "hunt" by chasing, cornering, attacking and fighting. So, why is it illegal to cause a dog to fight another dog, or a pig in an enclosure, but it is legal to use dogs to chase and viciously attack pigs while being trained and in the wild? Boar hunting with dogs is exactly what it sounds like: dogs trained to track and attack. They are taken out into the country, or wherever wild hogs are plentiful, and set loose to sniff out hogs. Once a hog is found the dogs will chase it down, corner, bay and attack it, usually leaving it badly injured, but normally still alive. Hunters (when they catch up) will kill the pig, usually by "sticking," which is a prolonged death vs. the use of a proper gun. Wild hogs are incredibly difficult to kill and will put up a fight until the end. Many dogs involved are wounded by tusks, bitten, trampled and sometimes killed. This is basically animal fighting, in the wild. Putting dogs in such a dangerous situation is inhumane and should not be legal. Visit http://sugarshope.org/ to learn more. PETITION LETTER: Wild boars are a major problem in Florida and in other states. The species has no natural predators, is omnivorous and repopulates very quickly: it is because of these traits that wild boars are a force hard to reckon with. There are many control methods used, some of them very inhumane. Currently it is legal for dogs to be used in wild hog hunting. This practice is extremely dangerous for the dogs involved and leads to inappropriate practices elsewhere. Dogs involved in hunting are likely to be seriously injured by the hogs. Dogs get trampled, bitten, pierced by tusks and may be infected with diseases that pigs carry. The hogs are frightened, outnumbered and suffer a painful death. I urge you to propose a ban on hunting wild pigs with dogs in order to put a stop to these inappropriate behaviors. Please consider other methods of wild pig population control, such as designating land for hogs to be displaced to, and controlling breeding of the species. Allowing dogs to hunt them is inhumane and unnecessary. Visit http://sugarshope.org/ to learn more. Sincerely, [Your Name Here]
We Demand that the U. S. Senate not confirm Andrew Puzder as Secretary of Labor
Andrew Puzder is among Trump's more controversial Cabinet picks because he has publicly opposed the overtime rule and various other Department of Labor regulations, and because the fast-food industry, from which Puzder hails, is a top wage-theft enforcement target at the department. Puzder is CEO of CKE Restaurants, which includes Carl’s Jr. and Hardee's. It’s actually very hard to imagine a worse choice for Labor Secretary than Andy Puzder. The Labor Secretary’s job is to look out for American workers. Trump's Labor nominee has opposed increasing the federal minimum wage from $7.25 an hour to $10.10 an hour and efforts to expand eligibility for overtime pay. It would be kind of funny if it wasn’t so serious. During the election, Trump made a lot of promises to create good jobs. But he’s filling his cabinet with CEOs and right-wing billionaires who have spent their lives undermining working people’s rights to come together in unions, while fighting minimum wage increases, paid sick leave and family leave policies. The evidence clearly demonstrates that protecting the rights of the people who work at Puzder’s company or its franchisees doesn't seem to be his priority. Puzder has run a business model that has produced widespread labor abuses at the companies. According to data compiled by Bloomberg BNA, over the previous seven years, about 60 percent of all Labor Department investigations of Carl's Jr. Restaurants found violations of the Fair Labor Standards Act. While working people at his fast food chains sometimes were making below minimum wage, Puzder was taking big compensation packages. In 2012, he made 291 times as much as workers at his restaurants. Now, he could be in charge of enforcing our nation’s labor laws—from ensuring workplace safety to investigating wage theft. His companies had the fourth highest incidents of wage theft reported to the government. ‘Wage theft is a rampant, everyday problem in the fast-food industry: Nearly nine out of 10 fast-food workers across the country report having money stolen from their paychecks by their boss,’ Kendall Fells, the Fight for $15 national organizing director, told Bloomberg BNA via e-mail. Bloomberg reported. “Fells referred to a 2014 poll commissioned by the campaign of more than 1,000 fast-food workers nationwide. The survey documented such common worker complaints as being forced to perform tasks before clocking in or after clocking out, having the cost of uniforms deducted from their paychecks, and not receiving breaks during long shifts.” Puzder’s Carl’s Jr. restaurant chain also has a history of sexist television. He thinks it’s appropriate to peddle sex to kids if it sells the product. “We believe in putting hot models in our commercials, because ugly ones don’t sell burgers,” said the CEO in a 2011 press release, according to Fortune. “We target hungry guys, and we get young kids that want to be young hungry guys.” Let’s target Puzder’s nomination instead. Just Say No Puzder at Labor. This petition will be delivered to the full Senate and to the Health, Education, Labor, and Pensions Committee of the U.S. Senate
Help Veterans & Dogs - Urge Congress to Adopt National Veteran Service Dog Standards
Here's one problem we can solve. Right now there is a lot of confusion over service, therapy, and emotional support dogs. Current service dog laws are being abused because there isn't a national standard. As a result, the validity of service dogs has been questioned. Veterans and their service dogs are being denied entry to public places, such as restaurants and airports. Many veterans report that their service dog allowed them to return to a normal life. Doesn't normal life include living without fear of confrontation? A variety of "service dog" bills have been presented in the House and Senate. We need one national standard. American Humane, National Association of Veteran-Serving Organizations (NAVSO) and a group of academic, business and government experts have created the first national standard for service dogs, but we need your help. Sign and share this petition today and let the House and Senate Committees for Veterans' Affairs know you support one common sense national standard for service dogs. Supporting this petition will ensure veterans and their service dogs have the opportunity to become credentialed. Let's help veterans and their service dogs live a life without fear of confrontation. #dogs4vets
Say Yes To Disability Rights
On February 15th, the House of Representatives passed HR620, the so-called Americans with Disabilities Education and Reform Act. Instead of stopping the few frivolous lawsuits that occur, the bill will roll back nearly thirty years of civil rights legislation for people with disabilities in the United States. By passing this bill, You will undo the foundation of the Americans with Disabilities Act, a piece of landmark legislation passed in 1990 that gives disabled people a chance at equal access to employment, education, and society in general. By voting yes, you will Force disabled people to endure a lengthy process that involves filing complaints with businesses when they face accessibility barriers. These businesses, some of which have violated the law for almost 30 years, will have up to six months to resolve accessibility issues, and even longer, if the businesses can demonstrate “substantial progress” toward resolution.No other civil rights law has ever put the burden on those it protects to start and maintain the enforcement process. HR620 places cost-cutting for business owners ahead of the human rights of people with disabilities. Imagine having to wait over six months to use the restroom, locate merchandise, or check out confidentially and independently when building codes and other provisions for your civil rights have existed for almost 3 decades. Republican Senator Jeff Flake of Arizona will soon introduce the bill to the rest of you in the United States Senate.Please, Senators, we urge you to vote against this unacceptable and unfair legislation. Do not weaken the Americans with Disabilities Act. Do not weaken current and future civil rights legislation for everyone by placing the responsibility for enforcement on those who need protection.Thank you for your attention.
Its called Respect for the Deceased.
As a mother that has lost a child in horrific car accident on 8.20.2016 I am now on a mission to STOP news cast from broadcasting the vehicle of the deceased. There is NO respect for people's privacy anymore . I did NOT want to see photos of my child's burning vehicle broadcast-ed. This is very personal space. This is where my child took her last breath, this is where her life was taken. That was my daughter in that vehicle. These photos will and are where the deceased loved ones search for answers. So I am now a MOTHER on a mission ..Please sign and help spread the petition you never know when you might be in my shoes.
Mattie's Policy- Medicine For Mattie, for ALL.
Attention: I'm doing this for my friend and the future of our health care. Jaclyn White. We have a victory for Mattie. Now, can we please keep this going to make changes for all who are in need of medicine. Let's make a change in policy, by signing this petition. Don't allow someone behind a desk make decisions on your life!! Doctors need to have the final say and what is best for their patience. Please share.... Something has to give. No more taking whatever is handed to us. You PAY for insurance and yet we allow them to dictate what they will cover. Stop this kind of abuse of power from Insurance and pharmaceutical companies! Mattie's Policy- for ALL with and without insurance, that need treatment for their life. Dear Anyone Who Can Help, I am writing you on behalf of my 9 year old son Matthew. We call him Mattie, and we live in Newnan, GA. He is a smart, funny, stubborn, bright young man who loves playing video games, feeding and caring for his chickens, and helping his family. Mattie had a 2nd surgery to remove a dangerous spinal cord tumor from his spine at C3-C4 that was compressing his spinal cord. Unfortunately, Mattie suffered a spinal injury during surgery. He also had issues with his heart rate and blood pressure after surgery that put him in the intensive care unit at Children’s Healthcare of Atlanta at Scottish Rite. They stopped the surgery and were unable to remove all of the tumor. At that point keeping Mattie alive took priority over removing all of the tumor. Since then, he has had to undergo intensive rehabilitation at Children's Healthcare of Atlanta. He was unable to walk, move his left arm, or feed himself after surgery. Thanks to the Rehabilitation program at Children's Healthcare of Atlanta, he is able to walk short distances and is gaining back his endurance. However, his arm is still paralyzed at the shoulder. As proud as we are of our son, his battle is unfortunately not over. His team of experienced doctors want him to try an oral chemotherapy called Mekinist in order to attempt to shrink the tumor. However, the FDA has only approved it for melanoma. They want to do something called using this medication off label. There are no other chemotherapies available on the market that will help him. Because of the FDA labeling, our insurances will not approve the medication. His doctors are doing all they can to help him get the medication. Matthew has UnitedHealthcare as his primary insurance, CVS Pharmacy (Caremark) as his prescription coverage, and Georgia Katie Beckett Deeming Waiver Medicaid (Georgia Department of Community Health) as secondary insurance. The drug manufacture Novartis, is denying him patient assistance because he has insurance. The medication costs are 1/10 of the cost of what it will incur for the costs of his surgeries and rehabilitation. It's more cost effective and logical for Mattie to try this medication. If it shrinks these tumors, he will be able to grow up and become a productive, tax paying adult. If these tumors keep growing, he will become a ventilator dependent quadriplegic. The cost to the state of GA and federal government for his long term care will be astronomical. It's in everyone's economic best interest to try to help Mattie get access to this life saving and tumor shrinking medication. Also, the cold facts are, that if he has more surgeries, he is likely to suffer more spinal injuries and quite possibly not survive. I am begging you as his mom to help. If you can help influence anyone to approve this medication for my baby, I would be forever grateful. You have the power to help him if you so choose. His life, future, ability to walk and grow up, are literally in your hands. Please help us. You could quite possibly be his only hope. All I want for Christmas is for my baby to get a chance at being able to use this medicine. Respectfully,Katie McKoy