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.
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
Pass legislation to turn on the FM radio chip in cell phones.
Did you know that every cell phone In the US has an FM chip which can receive your local FM radio stations? The problem is that the cell phone companies have turned the chip off in an effort to force you to consume more data. The purpose of this petition is to tell lawmakers to create legislation to require the cell phone providers to turn on the FM chip in cell phones. This will provide an equal playing field for terrestrial radio stations by unlocking the mobile interface while also giving consumers access to critical information during times of emergencies. When a hurricane strikes, radio is the only form of communication still able to reach the masses. It does not make sense that cell phone providers are blocking us from this free, potentially live saving content. Please sign this petition to tell your lawmakers to pass legislation that would require the FM chip to be turned on in mobile phones.
Stop "Predatory Price Increases" on Pharmaceutical Drugs
Please help support the Chronic Illness Awareness Coalition’s “Call to Action” that those in Washington "act and listen to the people", not lobbyists of large pharmaceutical companies, and hold Pharma Companies accountable for “Predatory Price Increases”. The issue: There has been an increasing trend of Pharmaceutical companies targeting both “Brand and Generic” drugs for those with Chronic Illness and increasing the price, of an EXISTING DRUG, by hundreds and sometimes over a thousand percent! And why? Because they know they can. They know that if you have a Chronic Illness you must take that medication, therefore you will pay whatever they charge. This is only a win for the Pharmaceutical company who implements this type of predatory price hiking practice. There is no proof of better outcomes from predatory price hikes, in fact the opposite, in many case people stop taking their medication because they cannot afford it. It negatively effects Health Insurance carriers as well, as the insurance companies have also complained this type of targeted price gouging drives up costs. Many carriers site the difference of what a member pays verses what the carrier pays on high cost generics, meaning a member may only pay $4 for a $800 generic medication. And it hurts the average tax payer in increased costs to Medicaid and other state and local county programs. A price hike of 300%, not unheard of, will causes costs of state and federal programs to skyrocket, raising all of our taxes. Again, the big winner here is the Pharma Company and it’s CEO. Definitely not the patient, the insurance company or the tax payer. Want proof? According to bloomberg.com(1) Feb 14 2017, about Marathon Pharmaceuticals and CEO Jeffrey Aronin "Marathon increased the prices of the two older, off-patent heart drugs, Isuprel and Nitropress, by almost 400 percent over two years" It’s reported that Mr. Aronin had done similar price hikes with other Pharma Companies; “Aronin was earlier chief executive of Ovation Pharmaceuticals Inc., which was sued by the Federal Trade Commission after raising the price of an older drug used to treat a deadly congenital heart defect in babies by almost 1,300 percent, from $36 a vial to nearly $500 a vial” According to Fortune.com from Sept 27 2016 (2) about Mylan Pharmaceutical and their CEO Heather Bresch “EpiPen has gone from $100 for a two-pack in 2009 to $608 today.” According to NYTimes.com Sept 20, 2015 (3) about Turning Pharmaceuticals and CEO Martin Shkreli “The drug, called Daraprim, was acquired in August by Turning Pharmaceuticals, a start up run by a former hedge fund manager. Turning immediately raised the price to $750 a tablet from $13.50…” All of these cases are about massive price hikes to medication already on the market with no significant change in to justify these types of price hikes. These are medications for babies, children, teens, adults and seniors that treat different conditions. But the one thing they have in common, they all treat a chronic illness that requires continued use of their mediation. What do we want? Allow Medicare and/or the Federal Government to price control or negotiate medication prices from Pharmaceutical companies. Those with Chronic Illness need protection from Pharmaceutical companies who engage in "Predatory Price Hikes". With our country’s (United States) collective buying power we should be getting a deal, not being overcharged, on prescription medications. What we need to do? This is a “Call to Action”! First: Please sign our petition Second: Get active and let your local representative know that we need accountability from Pharma CEO’s and “Predatory Price Hikes". Let Washington know that we need to protect our chronically ill friends and family from these types of predatory Pharmaceutical companies. Third: Join the Chronic Illness Awareness Coalition and help advocate for coordination of care and affordable, and accessible medication and treatment of Chronic Illness. Chronic Illness Awareness .org sourses 1 https://www.bloomberg.com/news/articles/2017-02-14/marathon-ceo-placed-steep-price-hikes-on-drugs-before-emflaza 2 http://fortune.com/2016/09/27/mylan-epipen-heather-bresch/ 3 https://www.nytimes.com/2015/09/21/business/a-huge-overnight-increase-in-a-drugs-price-raises-protests.html?_r=0
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!