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.
Stop Forcing Mail Order Pharmacy as Only Choice of Coverage & Monitor Package Temperature
My son, received a life saving liver transplant at the age of 2. His life depends on the potency and effectiveness of chemotherapy/immune suppression medications. In the past mail order delivered his liquid oral medications in nothing but a plastic envelope on a 102 degree day on a hot enclosed not temperature controlled UPS truck. Shortly after, he went into liver rejection which could have resulted in complete liver failure or death. I speculated that the medication could have been too weak after the delivery of medications in high heat. I vowed to never again risk his life with mail order pharmacy. Recently, we were mandated/forced to only use mail order pharmacy in order to receive coverage for his life saving medications. Hesitant, I begged for an ice pack. The package arrived on an about 90 degree day again without an ice pack. His labs elevated again afterwards. My son wants to know, "Why would they do that?" I contacted the manufacturer, who completes all of the testing for my son drugs who stated that both of my son's medications should be discarded and considered less potent once stored above 86 degrees as higher temperatures and freezing could result in lower potency. I also found out that the liquid medication that the youngest children take are the most harmed by the mishandling of medications outside of the manufactures temperature storage guidelines. Our youngest of children's lives are being threatened. I contacted the mail order pharmacy who refused to take replace or take back the medication. They said the law & USP Pharmacopoeia allows them to ship up to 104 degrees, although the manufacturer states it is not proven safe at these temperatures. I contacted the FDA, who states that the mail order pharmacy should be using the manufacturer's guidelines that have been proven safe. Not the reference range by USP that has not tested my son's exact medication. However since the mail order pharmacies are regulated loosley by the State Board of Pharmacy, not the FDA there was nothing that the FDA could do. I spoke with a UPS driver. He states temperatures on his truck are far above 104 degrees on a 90 degree day. He is mandated to keep his door closed unless getting a package. He states it gets so hot on a 90 degree day that he cannot breathe when he opens the back. I made over 30 calls to the insurance company begging for them to please let us pick my son's medications up at the local pharmacy at which they are filled. My son's physician wrote a note/appeal as his transplant team has stated that they have tried to voice their concerns about this issue with their pediatric/child patients and no one is listening! The insurance company still denied the doctor's appeal for us to pick up my son's medications in the safest way. It was not until the Media became evolved that the insurance company budged. I felt helpless and have untied with many other pharmacist, physicians, patients, mothers and fathers, and caregivers who feel the same way. Helpless. Mail order of prescription drugs should be a choice not the only option of coverage. Mandatory mail order programs from all plan types (INCLUDING the plans that are regulated by ERISA) needs to cease until mail order pharmacies are forced to store and monitor medications during their deliveries at the temperatures tested and proven safe by the manufacturer. I would never put my son's medications in a hot non-temperature controlled environment, and shoudn't be forced to only use this option in order to get coverage for his life saving medications. Mail order pharmacies may appear to save money, but when my son ended up in the hosptial after taking medications that could have been compromised by having lower potency, the cost of the rejection was thousands of dollars. If his liver would have fully failed, the cost of his liver transplant for just 5 days (he was in the hospital for 5 weeks) was over $1,000,000. The lax regulation and oversight may save money on prescription drug plans, but may come at an increased cost to the health plan itself. Also, keep in mind the endless waste of medications that automatically are sent regardless of whether or not patients need them. Also, people with chronic, complex conditions, should always have the option of face to face interaction with a pharmacist who knows their complex needs and medical history. Could you imagine being required to go to a different doctor every time you needed medical care for you or your family? The pharmacist and patient relationship is crucial to the successful outcome of the patient's overall health. Taking this away is harmful to patients and be more costly to our already stressed healthcare system. Another important fact. Mandatory mail order programs are discriminatory. It is estimated that 40% of our homeless are disabled. How is mandatory mail order fair and working for them as they may not have an address and not even know where they will be from day to day? We need legislation to protect all patients by ending the mandatory mail order pharmacy coverage in every type of plan offered in the nation. We need your help to make mandatory mail order an option not a mandate. YOUR URGENT SUPPORT WILL SAVE LIVES! THANK YOU!!
Remove sub-Asian boxes on Census Form 2020! Stop racist anti-Asian anti-immigrant legacy!
Dear fellow Americans for justice, brothers and sisters against racism, The glaringly racist legacy of sub-Asian boxes on the Census form was started in 1870, after the Burlingame Treaty of 1868, which eventually led to the infamous, racist, and inhumane Chinese Exclusion Act spanning from 1882 to 1943, which among other terrible abominations, banned U.S. residents of Chinese descent from having children or getting married; their family members in Asia were forbidden from entry to U.S. and reuniting as families. The Census form has no "Asian/Asian American" category. In its place are a group of boxes signifying foreign nationalities in Asia as if Asian Americans were all “perpetual foreigners.” It intrusively identified and collected data on which U.S. residents were of Chinese, Filipino, Indian, Vietnamese, Korean, Japanese...descent. While the Chinese Exclusion Act ended in 1943, did these racist, humiliating, dehumanizing sub-Asian boxes get removed from the Census form? No, they were kept on the Census form by the U.S. government even until today, and if we don't fight back and boycott the Census form with sub-Asian boxes, it will stay on the 2020 Census form and beyond, prolonging a racist American legacy, a shame to all Americans. This legacy treats Americans of Asian descent as perpetual foreigners, and collects intrusive personal ancestral origin data used in many kinds of racial discrimination and persecution. In one example, the U.S. government used information from the Census Bureau to identify native born Americans of Japanese descent and sent them to Internment Camps during the World War II. There were also discriminatory laws against Americans of various Asian descent, such as Filipino. Such horrendous trampling of humanity will happen again unless you and I act now to boycott a 2020 Census form with sub-Asian boxes. We demand these sub-Asian boxes be removed and replaced with one description--"Asian/Asian American." Injustice to one human being is injustice to all human kind. If we don't stop this racist and anti-immigrant legacy, its “logic” and mentality will be repeated in current and future policy-making. Let's keep fighting against racism and improve the human condition step by step. Please join the good fight to make this historically significant change happen for now and forever, by signing this petition and sharing it on social media and by email, word of mouth. Power to the people! Fighting on, Americans against racism and anti-Asian anti-immigrant legacy
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.