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Lamar Alexander

  • TN
  • Senator

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Petitioning Bernie Sanders

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  

Nicholas Grillo
801,493 supporters
Petitioning Donald J. Trump, Donald J. Trump, Secretaries of the Armed Forces and Congress, Ted Cruz, Elizabeth Warren, U.S. Senate, Bernie Sanders, Mitch McConnell, Marco Rubio, Dianne Feinstein, Kirsten E. G...

Hold Military Moving Companies Accountable

An Open Letter To Our Elected Officials - UPDATE 1 to the petition: https://militaryspousechronicles.com/2018/10/02/pcs-petition-brings-change/ Every year thousands of military service members and their families pack up and move on military orders. All of their memories, heirlooms, worldly processions, keepsakes, pro-gear, kids toys, and some useless stuff, otherwise known as household goods (HHGs) gets packed up by contracted strangers, loaded onto a truck and driven across country. If you are on the lucky side of things, your HHGs will arrive with a few scratches and maybe a broken bowl.  However, most everyone ends up on the other side. Boxes will be unloaded smashed and torn, furniture will come off broken in multiple pieces, and other items will just go missing. It will be brushed off as “don’t worry, you can just file a claim”, and while that might be true, there are things that money just can’t fix.  Money can’t replace the broken hutch inherited from my grandmother. Money can’t fix the missing foot board from the custom made bed. Money can’t fix my discontinued, now smashed in to pieces wedding china. And money can’t fix the box of my children’s baby memories box that never arrived.  I know, we should just leave these things with family! While that is a good thought, it’s not always possible. Some service members just don’t have the family available to leave these things!  Every year, thousands of service members  file claims with moving companies. Within the last 2 years the average claim has been around $10,000, with an average of only 50-60% of that being paid out.  Over the last 5 years, the PCS season has become more and more horrendous to deal with. The major moving companies being awarded the contracts, often sub contract out to smaller, local companies. Many of these companies do not understand how military bases work- usually sending drivers or crews who have a felony background, can’t access post, or a truck that has expired registration.  These companies also do a poor job in packing and handling of the HHGs. Many times the crew will pack as quickly as possible to get to the next job to make more money. In doing so, things are usually packed improperly, allowing for damage to occur. When loaded into the truck or unloaded at the storage facility or destination, everything is usually just thrown around without a care. When Service members and families speak up about how things are being handled, we are usually scolded, degraded, and told to just let them do their job.  In one of our recent moves we had a mattress come off the truck soaking wet. When I questioned it and ask what my son was suppose to sleep on, the driver took a furniture pad off the dresser and said he could sleep on that.  When we moved to our current location, I questioned the driver about my high value list, and the markings on the inventory about the furniture. The response I received was “this is just how we do it.” Then when we arrived, our range bags complete with range equipment were missing.  Our military service members and their families already sacrifice so much for this country. The deployments, holidays missed, birthdays not celebrated, their children’s firsts moments, training time, and sometimes even their life. Is it so much to ask that moving companies take a little more care in handling our memories? Is it so much to ask our elected officials to step in and protect our service members from the headache and heartache during a PCS?  I challenge you to start holding these companies accountable. I challenge you to step up your game and ease the worry burden on our military families.   MilitarySpouseChronicles #PCSChronicles #MemoriesSmashed         

Military Spouse Chronicles
106,247 supporters
Closed
Petitioning Food and Drug Administration, Lamar Alexander, Patty Murray, Mark Kirk, Dick Durbin, United States Department of Health and Human Services, Janet Woodcock, M.D., Office of New Drugs, FDA Public Aff...

Urge FDA to approve new treatment for Carcinoid Tumors

Hi. My name is Kerry and I’m a zebra. Now, before you think I'm crazy, I hope you'll please let me have a minute of your time to explain. In medical school, doctors-to-be are often taught the adage “If you hear hoof beats, think horse”. In other words, the most obvious answer is usually the right answer. But sometimes the hoof beats come from something rarer: a zebra perhaps. For nearly 5 years, doctors heard hoof beats as they looked at scans of my liver and saw some small “things” taking up residence. And, for nearly 5 years, they thought horse. They did blood tests, colonoscopies, upper endoscopies; all of the tests you would do looking for the “normal” cancers such as colon cancer, but the tests were negative. So they concluded that my liver had some benign growths on it. Nothing to worry about. In January of 2016 a biopsy of my liver resolved the mystery. I was diagnosed with a rare form of cancer called Carcinoid or Neuroendocrine Tumor (NET). The disease is so rare it is referred to as the zebra of cancers and represents only about 2% of cancers treated each year. In honor of its rarity, the zebra has been adopted as the official mascot of those who suffer from it and we, the patients, are called zebras. In my desperate quest for solutions to my problem, I read about a treatment called Peptide Receptor Radionuclide Therapy, or PRRT for short. It has been available in Europe for more than a decade and clinical trials here in the United States have recently concluded. The results have been very promising. According to one of the doctors who participated in the phase 3 clinical trial, “The findings were, in my opinion, extraordinarily impressive, the median progression-free survival improved by nearly 80%, which is fairly unprecedented in oncologic studies. The finding is important because limited therapeutic options exist for such patients, who comprise 20% to 45% of neuroendocrine tumor cases.” (1) As you can imagine, I have been following these trials with great interest as I am their target patient: my tumors are inoperable and are known to respond to the drug being used in the treatment. Earlier this year, there was hope the treatment would be approved by mid-year 2016. Then it was sometime in the fourth quarter of 2016. The latest timeframe for approval is now early 2017. I understand and appreciate the fact that the FDA has to perform their due diligence to insure that new drugs are safe and effective. None of us want unsafe drugs to be hurried to market. In the case of PRRT, it appears to have proven its worth, both in US clinical trials as well as in more than 10 years of use in Europe. I don’t profess to know or understand what the holdup is in obtaining approval. I’m certainly not a doctor. What I do know is that every day that passes without this treatment being approved thousands of us zebras get sicker and closer to the point where treatments won’t matter any longer. Will you please join me in urging the FDA to keep the approval of PRRT at the top of their priority list? I’m only 55 years old and I’m not ready to leave this world yet. I and my fellow zebras thank you. Kerry (1) Full article discussing PRRT can be found online at http://www.carcinoid.org/2016/05/03/one-step-closer-us-peptide-receptor-radionuclide-therapy-prrt-neuroendocrine-cancers/

Kerry Downing
65,057 supporters