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.
Tell the Senate to vote NO on Graham-Cassidy Healthcare Bill
We call on Senate to vote no on the Graham-Cassidy bill. Passage of this bill would result in millions of Americans across the country losing healthcare coverage. Approval of this bill would also result in massive cuts to the Medicaid program, sharply reducing or eliminating coverage for people who have disabilities, individuals living in poverty, and other vulnerable persons. We call upon Congress to work in an orderly, non-partisan, and meaningful way to find solutions that address problems with the Affordable Care Act that result in improved healthcare for all Americans.
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
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.
Support the DREAM ACT of 2017 to Protect Our Dreamers!
SIGNING AND SHARING THIS PETITION ARE THE MOST PRACTICAL ACTIONS YOU CAN TAKE TO PROTECT DREAMERS TODAY. Add your signature to this petition and urge your representatives and senators to bring the Dream Act of 2017 to the floor in both houses of Congress RIGHT NOW. Until then, our Dreamers are in jeopardy -- now more than ever. Make no mistake – phasing out DACA has already begun. We don’t have six months to wait. The Dream Act is resurrected! It has a long history in Congress, but no version of it has ever become law. Let's all come together as one, as #TEAMDREAMER, to save our DREAMERS by signing this petition in support of the DREAM ACT of 2017. The Dream Act of 2017 is already a bi-partisan effort. We need Congress to bring a clean Dream Act bill to the floor that grants PERMANENT LEGAL STATUS to Dreamers - without walls, e-verify or any other stipulations that will negatively affect other immigrants. Opponents of DACA are rationalizing President Trump's decision as a means to an end, toward holding Dreamers hostage in pursuit of their political, legislative or campaign agendas. We cannot allow the dream to end for 800,000 DACA-documented Americans when a practical solution is already in place and ready for a vote. Read more about The Dream Act at UnitedWeStay.org and UnitedWeDream.org.
Save Pensacola Beach and Navarre Beach
There’s a multi-billion dollar land grab moving through Congress.The Senate is working on S. 1073, the Escambia County Land Conveyance Act. The purpose of the bill is “To authorize Escambia County, Florida, to convey certain property that was formerly part of Santa Rosa Island National Monument and that was conveyed to Escambia County subject to restrictions on use and reconveyance.” Republican Representative Matt Gaetz has passed legislation in the U.S. House to sell off Pensacola Beach and Navarre Beach to private developers. The land is currently protected by a 1946 Congressional Land Conveyance that guarantees all leases on the beach belong to and must benefit the public. Gaetz' bill would take away these public land rights. Senator Marco Rubio has introduced the bill in the Senate, where it is currently in the Energy & Natural Resources Committee. The Public gains nothing and will lose Billions of dollars in valuable assets.The take-away here is that, with the demise of thousands of leases on Santa Rosa Island, the biggest winners are the tax coffers of Escambia and Santa Rosa Counties, and real estate developers. The losers are the residents of northwest Florida and the island itself. Barrier islands form to protect coastal areas. They are critical to healthy environments. Intact islands are important protection from rising waters, tides, and storm damage, so artificially breaching a barrier island is rarely good ecological practice. This is not a partisan issue. This would set a horrific precedent by reversing DEEDS and ownership to Publicly held lands This is a public vs. private, citizen vs. developer, greed vs. public good issue. If this could happen to Santa Rosa Island, which is entirely within the boundary of the Gulf Islands National Seashore and owned by the citizens of Escambia County, it could happen anywhere. The Escambia County Commissioners, working with Rep. Matt Gaetz and Sen. Marco Rubio, are trying to amend the original 1946 federal law that gave Santa Rosa Island to the citizens of Escambia County with two requirements: it must be used “in the public’s interest” and it could never be sold, conveyed, or disposed of, except back to the federal government. They seek to convey ownership of PUBLIC lands worth billions of dollars currently under lease to PRIVATE individual and business leaseholders. They also seek to convey public lands currently leased by Santa Rosa County and remove ALL conservation and preservation protections from that land. This would allow development of currently protected public conservation lands. This conveyance also allows Santa Rosa County the opportunity to pursue cutting an ecologically devastating new Navarre Pass.• We ask that the Escambia County Commissioners and Escambia County Supervisor of Elections include a binding referendum on the county-wide 2018 ballot.• This referendum will place the decision of maintaining or changing the PUBLIC lands status quo on Santa Rosa Island in the hands of the owners, the people of Escambia County.• The voters must have the opportunity to vote YES in support or NO in opposition on the binding referendum.
#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
Make Endometriosis A Recognized Disability In the United States
1 in 10 women suffer with Endometriosis which has no cure. Most of these women are in the twenty to forty age group (can be younger or older) and of the women who have this condition up to 40% are infertile. Unfortunately it can take up to 10 years for a woman to be diagnosed with endometriosis. Many struggle to keep jobs or have lost their jobs due to this painful condition. As of right now social security does not recognized endometriosis on the disability list. It is because they consider the pain to be intermittent and can be manged with medication which endo suffers can agree that that is not always the case. Too often women are turned down because of this reason. This petition has been made so that we can get this condition recognized as a disability in the United States. Too often we must suffer because we have no other resort. I hope that we can reach the white house and make this happen. Everyone please sign, this condition is so common that if you are not a sufferer yourself you know someone (mother, sister, aunt, daughter, wife, girlfriend, friend, etc.) that suffers from it. Thank you for your support!
Renewable and clean energy for Puerto Rico
After the destruction of Puerto Rico and it’s electrical grid by two powerful hurricanes Irma and Maria it would be ideal to reinvent how Puerto Rico produce its energy. These tragic events could present us a great opportunity like never before. Puerto Rico electrical grid and production plants are old and antiquated. This is the time to become energy independent of fossil fuels. Puerto Rico will rise, green like an emerald in the Caribbean Sea.