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
We demand that The United States Senate not confirm Jeff Sessions as Attorney General
As the nation’s chief law enforcement officer, the Attorney General of the United States must be independent of politics and respect the dignity of all Americans. The Attorney General has a duty to enforce the rule of law fairly and pursue equal justice under the law. One of the core functions of the Department of Justice is to protect Americans’ civil rights, and to defend those who have been denied them. Another key function of the Department of Justice is to protect our security, but never sacrifice our civil liberties. Not only has Senator Sessions been a staunch opponent of reforming the tragic shortcomings in our criminal justice system, he holds a number of views that are inconsistent with how most Americans believe justice should be applied under our Constitution.
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
Minnesota to secede from the United States of America and join the nation of Canada
With the recent election of Donald Trump for President of the United States, we, the people of the State of Minnesota, feel it is against our state's better interests to remain in the Union of the United States under such leadership. It is the people's opinion that this State now has more in common with the Nation of Canada than the United States when the President-Elect is sworn in. President-Elect Trump has a history of comments and potential policies that will openly discriminate against a large portion of Minnesotans that are of minority decent. This could include thousands of unlawful deportations or severe bullying and harassment of Minnesota citizens, families, and children. Mr. Trump also has several potential policies and opinions that are against the State's own laws of water and conservation, and game and recreation that could have significant impact to the western prairies and northern forests of this State. Culturally, the State of Minnesota is one of the most open and accepting States in America; with huge diversity in race, religion, and gender, in which Minnesota is leading the nation in equality for all. With Donald Trump as President, the State would be forced to recognize a man who is against such diversity and could force the State to backtrack on much of the progress it has made. We, the people of Minnesota, urge our State's leaders to consider the possibility of leaving the United States and join Canada. This would allow us to better maintain a way of life for all Minnesotans in terms of society, environment, and equality.
Tell policy makers to SAVE THE ENDANGERED SPECIES ACT
TELL POLICY MAKERS NOT TO GUT THE ENDANGERED SPECIES ACT! The Endangered Species Act, which was implemented in 1973, has protected 99% of endangered and threatened species from going extinct since its origin. The act was instrumental in the conservation and preservation of endangered animals like the bald eagle, the California condor, the gray wolf, and the grizzly bear among thousands of others. Currently congress intends to gut the act and transform it, removing vital protections for thousands of plant and animal species. This would not only have detrimental implications for ecosystems and habitats in our country, but it will negatively affect our economy in regards to eco-tourism. National parks with flagship species like the grizzly bear generate billions of dollars a year for our government, and thousands of people rely on these parks and their benefits in surrounding areas for jobs, etc. It is essential to protect the animals within these ecosystems, not only for the integrity of the future of our nation’s natural habitats, but also for our own economical, ecological, educational, scientific, recreational and aesthetic needs as humans. PLEASE sign the petition below to ensure that the Endangered Species Act remains in tact. Without the protection of the act, wolves will be shot and slaughtered without consequence, a bald eagle’s nest could be cut down out of a tree to make way for an apartment building, and grizzly bear cubs could be gassed alive in their dens. For more information go here - http://www.endangered.org/campaigns/protecting-the-endangered-species-act/
Demand Iron Panel Tests Go Back On Routine Blood Work: Prevent Deadly/Chronic Illnesses!
Iron Overload AKA Hemochromatosis, is the most common, deadly, treatable genetic disorder in America... not being diagnosed and treated in time! Numbers rival Diabetes but you've never heard of it! During early, damaging stages it's asymptomatic in 75 percent = silent killer. 2.3 Million undiagnosed, 2 million diagnosed too late, 15 million carriers who can and do get ill. Major trigger for heart failure, heart attacks, liver failure, cirrhosis, arthritis, Alzheimer's and a number of cancers. The irony is that both testing and treatment for iron overload are simple. A “Transferrin saturation” and ferritin tests show whether excess iron is being absorbed and at what rate. The 1998 decision to unbundle serum iron and ferritin from the routine executive blood panels closed a window for early detection/diagnosis. made no medical sense, and cost countless lives. Worldwide large population studies concluded that up to 40 percent of those with HH will get ill. It dwarfs ALS, MDA and MS in cases and is on par with diabetes, but few have heard of it... while they, their family members and friends die from it. Iron tests back on routine blood work makes medical sense, and would not only increase detection of iron overload, but Wilson’s Disease, anemia, cirrhosis, diabetes and Rheumatoid Arthritis. Far from a savings perspective, that 1998 decision actually increased healthcare costs. Before unbundling, a blood panel that included iron tests and a complete blood count cost $100. After, the same tests done separately cost $400. If iron tests were on the order for initial blood test screening an America Medical Association study noted diagnosis rates would rise 20 fold. 30,000 annual would become 600,000! Demand these tests go on the bundle of routine blood work immediately, and run with every CBC panel ordered. www.ironitout.org
Having the Minnesota State High School Hockey Tournament be a state holiday in Minnesota
We as Minnesotans like our events, for example the Minnesota State Fair. Minnesota is the State of Hockey, and we all know as students, workers, as Minnesotans, that the State High School Hockey Tournament is probably the biggest. Let's be honest, how many students, as well as workers, are watching it more than what they are supposed to be doing when it is on? I don't see it as a bad thing, but I have heard from MANY people when asked about The Tourney, say something like "It should be a state holiday" or "We shouldn't even have school." So I am asking that The Tourney become a state holiday so that all of us Minnesotans can relax and enjoy themselves, their family, as well as their fellow classmates and friends, for those three days we all love SO much. Students don't have to worry about school and workers get time off. It would be another "great Minnesota get together" we would all enjoy!
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.
To eradicate the "War On Wolves" and continue the protection of endangered gray wolves
The following is details taken from the website http://www.whitewolfpack.com/2017/01/minnesota-wisconsin-and-wyoming-have.html?m=1 and http://earthjustice.org/ "Senators from Minnesota, Wisconsin and Wyoming yesterday introduced the “War on Wolves Act,” a companion bill to legislation introduced last week in the House that would strip federal protections from wolves and allow trophy hunting and trapping of the species in four states. If the legislation passes both chambers and gets signed by the president, it would hand the fate of wolves in Minnesota, Michigan, Wisconsin and Wyoming over to states whose management wolf plans two federal courts ruled inadequate to securing the species at legally required population levels in absence of Endangered Species Act protections. In Wyoming, this would allow the state to resume a hostile management program that allowed for unlimited shoot-on-sight killing of wolves across 85 percent of the state. The legislation would further strip citizens of the right to challenge these lethal programs in court. The appeals process of two federal court decisions that restored federal protections to wolves in those four states are still underway. Decisions on those cases are expected any day." Politicians should not meddle in the science-based listing status of a particular species at any stage, but now is an especially bad time as these cases are still playing out in the courts. We urge those who support the protection of wolves to call their senators and representatives and tell them to vote down this lethal legislation.
Put An End To Animal Cruelty For Cosmetics!
I am writing to request that Congress pushes for comprehensive federal legislation preventing cosmetic companies from testing on animals and making cosmetic products tested on animals illegal. Have you ever realized the sacrifices made just for a pigmented lipstick and a lengthening mascara? I believe more people need to take a closer look into the companies they are paying and the consequences to innocent animals that will just continue every time you purchase a new product. Rabbits, hamsters, mice, and even sometimes dogs have harsh chemicals rubbed into their bare skin. These are just like the pets you may love and cherish right at home. Their lungs fill with poisonous fumes and lethal chemicals are poured into their eyes. Often bones are broken when they're held down struggling to survive. These animals never get a chance to be animals. The Organization For Economic Co-operation and Development (OECD) has experimented non-animal test methods that were successful which could spare the life of millions of animals. Thus, proving there are alternatives to animal cruelty. This behavior is cruel and no beauty product is worth the ugly price that is payed. Europe has already banned the sale of animal tested cosmetic products and we should have a long time ago. Federal legislation and laws are needed to protect these animals and turn companies into the right direction. Makeup lovers and animal lovers need to step in and speak up in order for there to be congressional action. I know Congress has many issues that are urgent and likely more important, but there has to be an end to this inhumane behavior. I am asking Congress to please pass laws against animal testing for cosmetics and ban these products.