Janet Woodcock, M.D.
- FDA Director, Center for Drug Evaluation & Research
Janet Woodcock, M.D.
- FDA Director, Center for Drug Evaluation & Research
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
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/
FDA Guidance for ALS
The US Food and Drug Administration (FDA) is responsible for developing guidance for amyotrophic lateral sclerosis (ALS). The guidance provides a roadmap to those in the ALS industry to navigate through the development of treatments. To develop new treatments for ALS, the guidance would incentivize industry sponsors by directing trials to be more efficient, predictable, and effective at assessing drug safety and efficacy outcomes. The FDA has failed to deliver the guidance in a timely fashion and is now culpable to the inhumane treatment of ALS patients. ALS is a progressive terminal neurological disease that can strike anyone at any time. The disease currently has no meaningful treatment. Patients are often told to get their affairs in order, and that they have 2-5 years left to live. You have a 1:400 chance of developing ALS in your lifetime and only 10% of patients live longer than 5 years. There is no typical progression of ALS; however, it eventually paralyzes every aspect of a patient’s ability to move. Eventually, patients are no longer able to walk, talk, swallow, and breathe on their own. A federal law in 2012 allowed for patient-focused drug development (PFDD). After extreme pressure in May of 2015, ALS patients finally met with the FDA to discuss the drafting of a guidance document. Due to the lack of urgency from the FDA, the ALS Association (ALSA) took ownership of creation to expedite the development of the guidance. In August of 2017, the ALS community submitted the results to the FDA. In February 2018, the FDA published the Draft Guidance that completely ignored the work of the ALS community. The open comment section closed in May of 2018 after receiving hundreds of comments related to the published inhumane boilerplate Draft Guidance. In July, ALSA convened with the FDA and advocates to discuss the guidance. Due to the lack of results, ALS patients and advocates met with the FDA in February 2019. At that time Dr. Janet Woodcock and Dr. Billy Dunn stated that the ALS Guidance would be published within 2 months. After this deadline passed without publishing the ALS Guidance many patients and advocates reached out to the FDA. The lack of acknowledgement by the FDA for missing their deadline truly demonstrated that the ALS community is not a priority. In June of 2019, another ALS advocacy group, No More Excuses met with some of the same people at the FDA. ALS patients and advocates are doing everything possible. However, the FDA ALS Guidance remains extremely elusive. The FDA must be held accountable and publish the ALS Guidance. We need you to sign our petition to hold the FDA accountable of their negligence to the ALS community. Below are immediate requirements of the ALS Guidance along with an example from just one current clinical trial (NurOwn): Using historical controls for placebo groups – FDA inhumanely required 100 terminal patients to get a placebo (fake medicine) injected into their spinal cord (3x) and receive bone marrow aspiration. There are clinical trials for cancer and HIV/AIDS that eliminate the requirement of placebo due to the inhumane nature of testing fake medicine on a terminal patient. Historical controls allow the use of more actual placebo data than the use of placebo groups themselves. It also prevents the deterioration that ALS patients are forced to undergo as they receive a placebo. Placebo trials in ALS are akin to forcing people to die "in the name of science". Wider onset criteria – Trials usually have inclusion criteria that are set less than 18 months from first symptom. It typically takes 12-18 months to be diagnosed with ALS, patients often have symptoms longer than that. This excludes many from clinical trials. This is inhumane and forces trials to take longer to enroll participants. Requirement of crossover or open-label – Patients have no access once they have completed the trial. Patients on placebo also have no access to the treatment after completion. There are patients who show improvement or slowing of ALS in trials that are forced to go home and continue deteriorating after the trial. Remove penalties for unmasking data to apply for Accelerated Approval – Due to the additional 100 patients and strict onset criteria, BrainStorm is still trying to complete the NurOwn trial as ALS patients die. If BrainStorm decides to unmask the data early to apply for Accelerated Approval they are at risk of jeopardizing the trial. Incentivize Agencies to provide Right to Try and Expanded Access to patients that don’t qualify for trials – Outside of one patient, BrainStorm has chosen not to allow Right to Try or Expanded Access. There are no incentives to allow terminal patients that don’t qualify for the trial access to this treatment. Innovative Guidance – The FDA routinely calls for innovative trials but requires ALS to have archaic designs. The ALS Guidance needs to be a responsive document that is quickly amendable as innovation evolves. A living breathing document will expedite updates and remove the slow federal bureaucracy that is occurring now. We ask for Executive Order or Congressional action to order the FDA to expeditiously publish humane and ethical Guidance for ALS and to hold those responsible for these failures accountable. Since 2012, roughly 50,000 US ALS patients have died waiting for humane ALS Guidance from the FDA. Please sign this petition to show your support. Authors Twitter: Corey Polen , End ALS Facebook: #StandForCorey , End ALS
A Penny for your thoughts. The push forward for the herpes vaccine.
Ask the FDA to fast track the vaccine for herpes. “Justice will not be served until those who are unaffected are as outraged as those who are.”― Benjamin Franklin "Are you tired of getting outbreaks? Are you tired of being sad, having suicidal thoughts because of your diagnosis? Tired of taking antivirals? Scared of HIV, and the possibility of Alzheimer's when you get older? I don’t blame anyone who feels this way. However, if you never speak up, then how would anyone realize that so many suffer? Remember the phrase 'see something, say something?' If people do not speak up, how can you expect help? Or any real change?"―Asking for a friend Hello, my name is Rich Mancuso and I was a participant in an experimental vaccine for herpes called Theravax, (now called RVX101 and RVX201) created by Dr. William Halford. Regardless of the past media hype, it doesn't change the fact that this experimental (and therapeutic), vaccine (not FDA approved), showed amazing promise and much more than the last 30 plus years of attempts of creating a viable and sustainable vaccine for herpes. I know, because myself and a few other people have received it and it worked amazingly. Unfortunately, some are begging for more of this therapeutic treatment, but it is not available to them and they continue to suffer in the worst possible ways. Since October of 2016, I have been volunteering my time  speaking about the Theravax (RVX101 RVX201) vaccine. Why? I think it is imperative that people are aware that hope is still alive for them and that I wish for many others to benefit the same way that myself and a few others have. It seems only fair since I know what it was like to suffer for over 25 years of herpes outbreaks but now I am doing amazing. I have found that over the past two years, the attempts of gaining any support for herpes is quite the difficult task. This is due to the stigma on herpes and the simple fact that no one wants others to know they have it. It's true, but the simple fact that herpes virus ( 9 different types) is millions of years old and infects over 90% of human beings, it seems so odd that we just beginning to talk about it. The truth is, close to 5 billion people have been exposed to herpes simplex, HSV type 1 and HSV type 2, commonly known has herpes simplex-cold sores or genital herpes. Fun fact, 80% of people infected don't even know they have it. This is because their immune system is working just fine. The crazy part of herpes is that most of these people do not even know they have been exposed. This is due to the lack of testing and the fact that the CDC does not recommend testing on individuals who are not showing any symptoms, because it doesn't change the patients behavior. Don't believe me? Click here. So why am I making a big deal about herpes? Why create a petition? If most people have it and they are doing just fine, than who cares? The millions of people who are suffering silently, care. The millions of people who suffer from neuralgic pain, care. The millions of people (world wide) who suffer from constant outbreaks, care. Also, there are many people who find that antivirals do not work for them and everything they try often fails. These are the people who care and wish for a better solution. This petition is to let the FDA know that many of us care and we care about our friends and family that suffer. There are many great strides in medicine and medical advances, we hear about them in the news all the time. These are the experimental drugs that get fast tracked so that patients can gain quicker access instead of waiting 15 years to obtain it. My suggestion to you is to sign this petition, write letters or emails and simply ask for help. Send emails and letters to the FDA, the NIH, local Congressman and Senators, and ask for help. If you suffer and want help, tell them. Tell them your story and ask them to contact the FDA and that YOU want this vaccine tested by the FDA, and wish it to be fast tracked.The FDA and the NIH is not a evil monster that simply eats funding. These are very complicated agencies that happen to be filled with people, just like you and me. Just like every other company in the world. Good people who wish to help. Make your voice heard that you want help. That you want a more serious effort towards herpes research and a working viable vaccine. Even if you don’t support my personal experience and the vaccine, I urge you to make your voice heard. It is just as important and more relevant now, more than ever. Don’t do it for me...do it for yourself and others! Ask for a real sense of urgency. Ask for more funding. Ask to please fast track herpes research or even ask to fast track RVX101-RVX201. It’s all up to you! Imagine is thousands of emails flooding the FDA and the NIH with simple requests. Imagine them taking herpes more seriously because they see the number of people suffering. Imagine them adding more funding towards herpes research. Imagine 2 minutes of your day sending an email and just asking. Nothing will ever happen by sitting silently and never asking the question. If you decide to write your local Congressman or Senator, please mail them your letter, with a penny taped to the bottom asking "A penny for your thoughts" The reason for this, is that any money they receive, they must account for. This will also emphasize the concern for herpes research. :) Please go to; https://pennyforyourthoughtscampaign.com/ Info on Dr. Peter Marks M.D. PhD. Director - Center for Biologics Evaluation and Research (CBER) https://www.fda.gov/node/369162 Email: OCOD@FDA.HHS.GOV https://www.nih.gov/about-nih/contact-us firstname.lastname@example.org https://www.fda.gov/…/Enforc…/CompliancePrograms/default.htm  I do not work for Rational Vaccines or any other vaccine company.
Demand more research for Fibromyalgia sufferer's
We are being left painfully disabled and confused, its unacceptable and should be a crime. Fibromyalgia sufferers are being failed and we need the help of other chronic pain warriors and our healthy friends to get loud and demand the research we deserve! We are being dramatically taken advantage of and failed by the medical community who are pushed to feed us high paying antidepressant pharmaceuticals as the only option for our pain. They are ineffective for the vast majority that I've polled. It also leaves many of us in a continued state of pain and desperate for relief but too tired and lethargic to fight for more medicine in fear of being called a "drug seeker". We are suffering in silence and pain with nobody to speak on our behalf, too weak to speak up alone as we are put into an even deeper brain fog with the meds they give us. We are getting lost in the medical shuffle and we need your support to demand more research. We know what works for pain and the days of us being silenced have got to come to an end. We are made feel shamed when asking for pain management and that time is OVER! We know pain better than most people will ever comprehend pain and we battle through it on a minute to minute basis. I did not ask for my life to change and become filled with painfully stiff mornings, unmanageable days, and uncomfortably painful broken sleep patterns. This happened to us, we didn't ask for it, and we deserve far more research and pain management than we're getting. I'm tired of being pushed to get on "high paying" anti depressants offered by big pharmaceuticals. I'll add that if you're one of the few managing through this pain by using those medications this is a no judgement zone and I will always encourage and support anyone to do what they feel is best for them and their family. I personally had 3 natural births without medication and postpartum I refused all pain meds that were offered to me. I have a high pain tolerance and as a "hammer and nails kind of girl" I've always been one to "tough it out". Let me tell you, the day I had my first fibromylgia flare was the last day I had those feelings. I was immobilized by the pain and desperate for relief. The pain literally shook me from my head to the bottom of my feet. Without warning I was unable to lift my head off my pillow, I could not lift my hands up and into my jacket while getting ready for the ER visit ahead of me, and all the while was moaning in more intense pain than I had ever felt or imagined. I suffered in pain at the ER for 8 hours until I finally was given the pain relief a Fibromyalgia sufferer deserves. There are some fibromyalgia fighters who have found relief in a combination of fully natural remedies or a mixture of natural and narco pain management. This decision needs to be made on a case by case, doctor and patient basis. The barely effective antidepressant push is not working and doctors are not listening to us! This is why we are so desperate for your help. We need the help of the healthy community to step up and speak beside us. Please invite your friends and family on this journey with us. Just because I get brain fog, overwhelmed easily, and consumed in debilitating pain, doesn't mean that we should be taken advantage of. We have been lost in the big pharma politics and it should be considered a crime to let us suffer like this. We have the right to enjoy a high quality, limited pain lifestyle. We deserve the right to have access to more effective and custom pain management solutions. We are offering a beautiful, small piece of jewelry, as a thank you gift for donations larger than $50.00. 100% of the proceeds are going to our mission. The days of doctors using our illness for patients that they are unable to diagnose are over. With the accurate blood test offered by Epic Genetics (I have no affiliation with) called Fm/a we will begin to weed out those who don't truly have this illness while making it impossible for doctors to misdiagnose people going forward. This blood test is our only hope at progress. For those of us who's insurance will not cover the Fm/a test we have to come up with close to $1000.00 to prove our illness per person. These donations will go directly to support getting us tested one by one. Please help us on "Our Journey" by donating, sharing, and getting the word out about how we are being neglected and taken advantage of. We deserve to live, not just exist. Visit our Facebook Group - Fibromyalgia: Our Journey Blog - www.fibrotraveler.org
Please Help to stop PROP's Petition
This petition is for all of us who suffer from chronic pain ! and our right to stand our ground and Have a voice in this matter! By petitioning the FDA to save our rights to relief from the suffering and pain we experience day in and day out. Chronic pain sufferers have a voice that needs to be heard. We as chronic pain sufferers out-number these that are trying to limit our access to opioid medications. The more signatures we receive on this petition the louder our voice will be. If the FDA accepts the changes asked for by PROP it will limit our rights to receive the opioid medications we have to take to have some sort of quality of life. For chronic pain patients opioids allow us to get dressed in the morning, get out of bed, and do some activities we had prior to our onset of pain and the life changing experiences we have faced due to our chronic pain. Please not only take a few moments to sign this petition so the FDA can hear our unified voices loud and clear, but please join in our fight by sharing this petition. Together we can stop this. Together we have a voice! Together we will save lives!
We need more FDA approved treatments for cystic fibrosis. We are running out of time.
Cystic fibrosis (CF) is a horrible and debilitating disease that affects many parts of the body, including the lungs, liver and pancreas, among other organs. It’s also incredibly rare – only 30,000 Americans have it and there are just 1,000 new cases every year.I know this disease all too well. I have two daughters who suffer from cystic fibrosis. Keeping them mentally strong to deal with CF while also keeping them physically healthy has been the challenge of my life. CF is a daily battle with a chronic illness that threatens another bout of pneumonia or a new infection that could threaten my daughters’ lives. My girls, and thousands of other young adults with CF, need the drugs the FDA is currently considering. Time is not on our side. I always ask those in positions of leadership: If your child was in the position that mine are in, would you make these drugs more easily available?In recent years, the Food & Drug Administration (FDA) has approved groundbreaking new treatments that help patients with specific genetic mutations of the disease. It is truly a new day for many families living with CF, including mine, who are in a race against time. The average lifespan is late 30s to early 40s, but the promise of new medicines will help ensure that people with this disease live longer and healthier lives. The FDA should be commended for its work on past CF treatments, but we can’t stop now. Please sign my petition today to encourage FDA to quickly review and approve precision medicine treatments for CF where strong science and sound data exist.We simply don’t have time to wait! Your support means everything to me and the thousands of others fighting this horrible disease.
Insulin For All
Insulin prices have been increasing tremendously through the years; it was just $1 for a vial in 1921. Now, it is a ridiculous cost of $255 for ONE single vial. The big three: Novo Nordisk, Eli Lilly, and Sanofi (companies that produce insulin) claim that the vials produced today has a lot more benefits than before, but this has been debunked multiple times by multiple health experts. The only thing that has changed since is the packaging. People with diabetes have been paying almost ten thousand dollars annually in order to survive and it will keep increasing if we don't do anything about it. This is absolutely not okay and SHOULD NOT be happening. Many have lost their lives or their loved ones due to rationing or simply not having enough money to buy insulin. To insulin manufacturers: lower insulin prices. Everyone should have the access to the necessities they need. It is not a privilege nor a luxury - it is a human right.
Demand that Fibromyalgia sufferers get the Pain Management we require!
Fibromyalgia may affect someone very close to you and you may not even be aware of it. This chronic pain lasts all day long, some minutes worse than the last. You never know when you may "flare up" (a flare up is a pain so intense and widespread that you become immobile until it passes, shoulders tense, extreme tenderness and pain from your collar bone to the thighs and calves and even your heels, it comes with blinding headaches and inability to move your neck). Since there is not much written or documented regarding this illness we don't have a cure, don't know the root cause, and there is not an effective treatment plan. Many doctors will not even attempt to treat a Fibromyalgia patient because of the unknowns and lack of options. Well, us Fibromyalgia sufferers have figured much of it out on our own by forming online groups and sharing personal experiences. We don't want to be put on nerve blockers and anti depressants that cause more side effects than actual treatment. Anti depressants effect how 1 in 4 fibromyalgia patients receive pain and even when it works for those rare few it comes with a backlash of side effects from depression (which they didn't have prior), to extreme fatigue, shakes, paranoia, and much more. Eventually, it stops working for those rare few that it initially seemed to helped and they are stuck withdrawing from pills they should not have been on in the first place. As a busy wife, mother of 4, with a full time career I do no have the luxury of waiting it out until the doctors figure something out for me. I don't want to become immobile and disabled because they refuse to give us the pain management we deserve, the pain management my family deserves. Many of us end up severely depressed because of the extreme pain we have difficulty accepting and lack of help we receive. The first step to Fibromyalgia is acceptance. You have to accept that the life you lived is over and you will have to live a new life with limitation's on stress and activity. I was an avid hiker in my previous "well" life and a spontaneous 5 mile hike on a Saturday was common for my husband and I. Now, my hips feel like they are grinding and about to pop out of socket after a mild 10 minute walk. The grieving process was intense and the more I cried and resented my new life the more painful my body ached and the less mobile I became. Now that I have accepted a new lifestyle of lessened activity combined with minimal stress with a combination of pain medication for flare up control and cannabis oil/thc for daily sustainability, the pain, although still constant, is more frequently a level 5/6 rather than 7/8 and my flare ups are fewer at 10-14 days per month rather than 20-25 days. When you live in chronic pain you start to see people and life in a much different light. You begin to empathize in a much deeper way. I recognize other pain sufferers by how they move and look around the room before adjusting their body or squinting from light sensitivity. It's a world I was very blind to previously and has made me realize how LOUD we have to be to make our painful world know to the "well" community because we need your help too. The flare ups are still here, so what do we do when we feel the more intense pain coming? That is when we must rely on pain killers (hydrocodene 5mg as needed) for emerging pain at minimum. If you get ahead of the flare up early enough you have a greater chance of preventing a full blown flare that will leave you in immense, immobile, pain. If you don't, you can at least keep the edge off until that unbearable, immobilizing, tear draining pain, decides to pass. During one of my first flare ups I was in such intense pain that my wrists became limp on their own and I was unable to turn my shower knob. I broke down crying on the floor desperately seeking my old self would return and pick me up to tell me this is just a terrible nightmare. That never happened. Instead, I took a pain pill, got a hot heating pad, lifted my legs, sprayed on some magnesium oil, and let the tides pass. Eventually, the flare passed and I was tricked into thinking I could be somewhat the old Johana, but I was wrong, and a few flare ups later I learned that my super active and constant moving life was over and I'd have to find a new way of living to get my daily tasks accomplished. A way of living that would contain all day pain, weakness, headache's, and body stiffness. Don't lay down too long with fibromyalgia because you will experience the sort of stiffness you had no idea even existed (tin man from Wizard of Oz comes to mind quite literally). So here I am, telling the world my story, because I have spoken to thousands of fibro warriors that suffer the same daily war I struggle with. Its quite a war on my body but was even more so on my mind in the very beginning. Now that my mind has adjusted, I am here to DEMAND better pain management from the medical community. We are being let down by our doctors who are too afraid to treat us because its not "an official form of treatment". Says who, the guy behind the keyboard whose wrists feel just fine when he types? Because mine are about to fall off from typing this up, and just last year I could write you a 20 page paper in less than 2 hours. Life has changed and the medical community needs to recognize that as well. We need your help to get pain management. No, we will not accept anti depressants and nerve blockers as the medical communities safest and most profitable way out! They don't work! Give me daily cannabis oil with a small amount of thc combined with AT LEAST 10 days of hydrocodone. I say 10 ten days, because the cannabis oil may likely control our flare ups at least 2 out of 3 days if taken properly. Unfortunately, without a root cause or cure the flair ups are inevitable and they are too painful to function under. It should be considered a criminal act that doctors allow us to suffer knowing the all over body pain we are forced to manage through, criminal! The main reason they refuse to give pain medicine is because of the opioid crisis. My answer to that is limit us to a set number of days relief with pain meds that, as adults, we can take and control on "as needed" basis. We learn to live with pain and we accept it so we are not requesting pain meds all day, every day. It is impossible to become addicted at 10 days a month and at the very least we have earned the right to be responsible for our own painful emerging pain and flare ups. We are adults and we are in pain! We DEMAND pain relief through a the following at a minimum mix of: thc/cannabis oil for daily sustainability and 10 days worth of pain pills for controlled flare up management. We REFUSE to sit around in pain, becoming disabled one by one, and being fed with ineffective treatments. If anyone understands PAIN it's a fibromyalgia patient! Please note that this request is "at minimum" since most doctors don't even offer flare up maintenance with pain pills at all for us suffering in tremendous pain. Once a minimum is established on a national level individual dosing should be discussed between patient and doctor, on an individual level, since each person is experiencing different levels of pain. I ask you to stand by us by signing and sharing this petition so that it gets the attention of people who can make it happen. We need it here and we need it now. https://www.facebook.com/fibrotraveler/
Protect the Horseshoe Crab as an Endangered Species
The horseshoe crab's (Limulus Polythemus) unique blue blood saves human lives. It is used to detect endotoxins in all medicals agents, IV injections and medical devices at the ppt (part per trillion) dilution. The FDA requires all medical substances be tested using LAL (Limulus Amebocyte Lysate) test derived from the horseshoe crab blood. This is one reason the 445 million year old crab population has shrunk by 75% in the Atlantic coast area. Medical Labs need to handle the horseshoe crab with care to avoid over bleeding and re-bleeding frequently which increases their mortality by upto 30%. Please help protect the horseshoe crab by classifying it as endangered!.