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.
Congress: Censure President Trump For His Heinous Remarks About "Shithole" Countries
Please also sign and share our net neutrality petition: https://www.change.org/p/jeff-flake-we-need-one-more-republican-vote-in-the-senate-to-save-net-neutrality And join our group here: https://www.facebook.com/groups/1721640631484675/ ----------- This petition began in a private, politically active facebook group of 6300 people consisting of Democrats, Independents, Socialists, Libertarians, and concerned Republicans. On Thursday, Jan 11, the Washington Post reported that President Donald Trump attacked potential immigrants from Haiti, El Salvador and African countries as part of a bipartisan immigration deal. The White House did not deny these allegations. This, a day before the 8th anniversary of the earthquake in Haiti that killed over 100,000 people. This is a step too far. If this were any other president, a censure would be an expected course of action. We realize that many in congress have become numb to Mr. Trump's rhetoric, but American voters have not. This is the language of fringe talk radio, not the President of the United States. He dishonors the office with these words. He is our chief diplomat around the world, and he represents millions of Americans who emigrated from these nations. He should act like it. It is time for congress to stand up and censure this president for his dishonorable remarks about our friends in Haiti, El Salvador and Africa, who rightfully look to the United States as a beacon of freedom and opportunity.
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
Protect the Public Service Loan Forgiveness Program
Update: February 13th, 2018 President Trump's proposed 2019 Budget calls for the COMPLETE ELIMINATION of the Public Service Loan Forgiveness Program (PSLF) If you care at all about PSLF then NOW is the time to take action. President Trump's Proposed 2019 Budget was officially released yesterday and clearly calls for pulling all funding from the Public Service Loan Forgiveness Program, along with making several other massive cuts to Federal student loan programs. RIGHT NOW is the time to post this Petition on Social Media, in the comments on related news stories, to your Blog or anywhere else that you can think of where people who care about PSLF and student loan debt will find it, because unless we can show the Congress that there's a huge contingent of Americans standing in support of PSLF, it's likely to be cut for good. Don't let President Trump and Education Secretary Betsy DeVos have their way on the student loan crisis. Don't let the big banks and corrupt for-profit schools continue to rake in trillions of dollars from hard-working Americans. Stand up for this vital program that supports people wanting to better their lives and give back to their community by making this country a better place! We ask that Members of Congress block President Trump's Proposed 2019 Budget until it includes support and continual funding for the Public Service Loan Forgiveness Program. --- In addition to eliminating PSLF, President Trump's Proposed 2019 Budget Seeks to: Reduce available Income-Driven Federal Student Loan Repayment Plans (IDR Plans) from 4 to 1 Increase Monthly Payments for IDR Plans, raising the Discretionary Income Cap from 10% to 12.5% Offer Loan Forgiveness earlier to the general public, offering it at 15 years instead of the current 20 (this is the one good thing he's seeking) Require Graduate Students to make 30 years worth of payments before receiving Loan Forgiveness Eliminate all Federal Subsidized Loans, meaning that all Federal loans will begin accumulating interest even while borrowers are still in school Embolden the Federal Government to go after borrowers who default on their loans NOTE: These changes will ONLY APPLY to loans borrowed AFTER July 1st, 2019, so people already in repayment do not need to worry about these changes, but they are serious and significant cuts to the benefits that future generations will be offered, which is why it's so important that we stand up for them NOW! For specific details on exactly how President Trump's 2019 Budget will impact student loan laws, student loan forgiveness and specifically the Public Service Loan Forgiveness Program, please visit: https://www.forgetstudentloandebt.com/student-loan-relief-programs/federal-student-loan-relief/federal-forgiveness-programs/president-donald-trumps-student-loan-forgiveness-program/ --- The Department of Education is proposing eliminating the Public Service Loan Forgiveness Program. The stated purpose of the Public Service Loan Forgiveness program is to “encourage individuals to enter and continue to work full-time in public service jobs”. To qualify for PSLF forgiveness, people must not only work full-time in a public service position, but also make 10 years’ worth of full, on-time, income-based monthly payments toward their Federal student loans. Who receives PSLF forgiveness? Teachers, Government Employees, Non-Profit 501(c)(3) Employees, Police Officers, Fire Fighters, Park Rangers, Military Personnel, and other qualifying public service workers. 400,000 Americans have chosen to serve their Government and Communities over the past 10 years, and each of these Americans should be able to count on the PSLF benefits promised to them. Betsy DeVos’s Department of Education seeks to end PSLF without having conducted a detailed study to determine how much actual money this dramatic policy reversal and broken promise would even save. The plan to eliminate PSLF is an not only an insult, but also an outrage to everyone who has dedicated the past ten years of their lives working in public service positions. Ending the Public Service Loan Forgiveness Program is a terrible idea that should be opposed at all costs. We ask that Members of Congress block the Department of Education’s proposal to kill this vital financial assistance program.
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.
Justice For Destiney, Put a STOP to Child Molestation
When someone does something wrong, you expect people to be held accountable for their actions. In this case, her seventeen year old half brother wasn't. When someone does something inappropriate to you they always tell you, especially as a younger child, to tell someone so they can be punished for their actions. Unfortunately, Destiney this nine year old girl, as frightened as can be did exactly that and still didn't receive the justice she deserved. He, who's name cannot be mentioned, helped destroy and damage her thought of mind and her train of emotions. Yet, as soon as she finally let it out, she knew something had to be done. She's spent months going through court cases, hearings, meetings, and still she did not receive justice. This poor nine year old girl was turned down by the Milwaukee Wisconsin District Attorney and her case was let go. It wasn't fair because this was suppose to be her own blood brother and he molested her, more than once and still was given "the right" to walk around without a care in the world... All he got was a night in jail and the unfair right to live as freely as can be. He knew what he had done and knew it was wrong but claimed all times were just an "accident". Destiney and all her stories she had told the police remained exactly the same. She started falling behind in school and even missed school to attend more hearings and even therapy. In which she found out that she lives and suffers from PTSD, but what was the point of telling anyone when nothing was done. Yet, till this very day she lives in fear that something like this will happen to her and that he will come back to harm her for telling someone and it's all because of him. So all that we ask is to please help Destiney and I her mother, get the justice she deserves so my daughter doesn't have to live in fear. We need her case to be reopened and for him to be punished for what he had done to her, so please take the time out your day to sign our petition. It's very appreciated she deserves to live at peace and we thank you so very much in advance.
#SAVEH2B: Save Small & Seasonal Businesses!
PLEASE ASK CONGRESS TO #SAVEH2B AND SUPPORT IMMEDIATE CAP RELIEF! American Small and Seasonal businesses are currently approaching their busiest season of the year and they will not be receiving their seasonal guest workers. Without these legal, temporary employees American businesses and workers are in jeaprody. The H-2B Visa nonimmigrant program allows employers to hire foreign workers to come to the United States and perform temporary nonagricultural services or labor on a one-time, seasonal, peakload or intermittent basis. H-2B workers are not considered immigrants. In order to qualify for an H-2B Visa, an employer must prove that there are not sufficient U.S. Workers who are capable of performing temporary services or labor. MYTH: H-2B WORKERS TAKE JOBS AWAY FROM AMERICANS.FACT: American workers are guaranteed first chance at every job later filled by an H-2B temporary laborer. By law, every open position must be properly advertised in the community and requires employers to hire any able and willing American workers to fill open positions. The fact is that H-2B temporary workers actually support American jobs and the U.S. economy. The H-2B program provides an opportunity for seasonal businesses to operate at a greater capacity, thereby retaining their full-time American workers and contributing more to their local economies. Additionally, temporary foreign seasonal workers help support many upstream and downstream jobs. According to the American Enterprise Institute study on Immigration and American Jobs, every H-2B worker creates or sustains 4.64 American jobs on average. MYTH: EMPLOYERS DON’T EVEN TRY TO HIRE AMERICAN WORKERS TO FILL THESE TEMPORARY HARD LABOR JOBS.FACT: Employers work extremely hard to hire American workers because 1) it is dramatically cheaper to do so, and 2) the law requires that employers demonstrate that every effort has been made to hire Americans before they can start the process of trying to hire a temporary foreign laborer. Again, the fact is that the vast majority of American workers are not interested in temporary seasonal manual labor jobs. Geography is a big obstacle for many employers; for example, many resort communities don’t have a sufficient local labor pool. And, in many cases, these types of seasonal jobs may not be appropriate for high school students due to the hours or labor laws that prohibit the use of heavy machinery by minors. MYTH: PAYING HIGHER WAGES WILL ENTICE AMERICAN WORKERS AND SOLVE THE SEASONAL TEMPORARY LABOR SHORTAGE.FACT: Hourly pay for these types of jobs have gone up significantly over the last few years because employers who use the H-2B program are required to pay their H-2B workers and similarly employed American workers a premiumwage dictated by the U.S. Department of Labor. These temporary manual labor jobs often pay considerably more than the minimum wage, but American workers still won’t take the positions. Sadly, in many cases, employers who obey the law and use the H-2B program are often competing against businesses that choose to illegally hire undocumented immigrants and pay those workers considerably less. If wages were raised even higher, seasonal employers who use the program would not be able to sustain their businesses or their American workers. MYTH: THE H-2B PROGRAM REPRESSES WAGES FOR AMERICAN WORKERS BY PROVIDING A CHEAPER LABOR SOURCE.FACT: Hiring H-2B workers is a much move expensive and risky option. In addition to the fact employers are required to pay H-2B workers and similarly employed American workers a premium wage that is often well above the federal minimum wage, complying with the H-2B program is extremely costly, complicated and wrought with uncertainty due to an overly restrictive cap and a constantly changing regulatory environment. Employers turn to the H-2B program as a last resort, after extensive efforts to recruit American workers. MYTH: H-2B WORKERS OVERSTAY THEIR VISAS AND EXACERBATE ILLEGAL IMMIGRATION IN AMERICA.FACT: According the U.S. Department of Homeland Security visa overstay in the H-2B program are rare. Workers who do overstay their visas are barred from using the program ever again. The fact is that the vast majority of H-2B workers and their employers are meticulous about compliance. Not following the strict program rules means the end of a well-paying seasonal jobs that allows these workers to provide for their families and still maintain their homes in their native countries – a risk these workers are not willing to take since they generally return to the same employer year after year. Additionally, when approving H-2B visas, the U.S. Consulate confirms workers’ ties to their home countries. Further, the U.S. Department of Homeland Security requires employers to promptly report any H-2B workers who do not report for work or who complete their work earlier in the season than anticipated. MYTH: THE H-2B RETURNING WORKER EXEMPTION IS UNNECESSARY.FACT: The H-2B program’s annual 66,000 cap (33,000 for each half of the fiscal year) is not adequate to meet the demands of a growing economy. The cap for the first half of the fiscal 2017 was reached on January 10. The second-half cap was reached on March 13, leaving many seasonal employers shut out of the program with no access to legal seasonal laborers. Without the returning worker exemption passed by Congress with bipartisan support and signed into law by the President, many companies will have to close their businesses, lay off American workers or turn away customers.This provision is essential to the survival of small and seasonal businesses across the country and should be made permanent. An H-2B returning worker exemption is a narrow solution to a seasonal workforce shortage that focuses on workers who are valuable to their seasonal employers and who have never violated the terms of their past visas or other U.S. laws. These workers do not pose a security risk and they are not taking away jobs from Americans. For more information please visit: https://www.SaveH2b.orghttps://www.h2bworkforcecoalition.com https://youtu.be/UTYVEirlu3o To contribute further, please contact your Congressmen/women and tweet using the hashtag: #SAVEH2B
End Kitten Mills
Kitten mills are places where female cats are bred and bred over and over to make many litters of kittens. The kittens are born with diseases because the female cat had many diseases due to shortage of water, starvation, and filthy places to stay. The kittens that are bred are usually cramped together in a tiny cage filled with old urine, bugs, and dirty food. Kitten mills ordinarily take place in small houses that are not taken care of. Kittens are also found dead on a daily basis because of all the filthy conditions they are in. This problem impacts all animal lovers and people who want cats as pets. TIP: Don't buy your pets from pet stores because the animals usually come from kitten or puppy mills! Help put a stop to this by signing the petition! Thank you and #StopAnimalAbuse
Expand the post-9/11 caregiver program to all U.S. veterans
Many of our military veterans have health issues stemming from their service to our country in foreign wars. These issues often require ongoing caregiver assistance. Veterans who served after 9/11 have received the most generous benefits, which has left our other veterans scrounging to cover needed care. Senator Patty Murray’s latest attempt to bridge this disparity, the Military and Veteran Caregiver Improvement Act, has been stuck in Senate committee since 2015. This act is important because so many of the caregiver programs are geared toward post- 9/11 military veterans. Meanwhile, the veterans of our wars in Korea, Vietnam, the Persian Gulf, and others have been forced to rely on their family and friends for needed care. Many spouses are faced with the tough choice to put their loved ones into a nursing home so they can get a job to help support their family. Others, like my own mother, stay at home to care for their veteran and are forced to scrape and scrounge every single penny to make ends meet. Veterans from all eras have sacrificed to serve and protect our nation. They have seen and experienced things that few of us could even imagine. And many of them have been exposed to weapon materials that are extremely toxic and dangerous -- leaving them with ailments that plague them for the rest of their lives. We have to do more to care for these heroes. If you believe that our veterans are valuable and deserve the resources necessary to ensure a decent quality of life. If you agree, please sign and share this petition to tell Congress to pass the Military and Veteran Caregiver Improvement Act, or a bill similar in wording.