Federal Drug Administration
Federal Drug Administration
ALS patients can’t afford the wait. Fast track decision on bring drug to the United States
It’s been over 20 years since a new treatment for ALS, a progressive neurodegenerative disease that affects nerve cells in the brain and the spinal cord, has been available in the US. That could all change with Radicava, a drug already available in other countries and that extends the lives of those with ALS. The Food and Drug Administration (FDA) is reviewing the drug and say it should make a decision by summer of 2017 -- that is too long. And even if a decision to bring the drug to market is reached, it could take 6 months to get it to pharmacies. People suffering from ALS need this drug, thousands of patients will not make it that long and need access as soon as possible. This isn’t the case of a drug that has never been available to the public and where higher scrutiny would be understandable. Radicava has been available in Japan and South Korea, and hasn’t shown anything that would indicate it is not safe. Sign our petition telling the FDA to expedite their decision. People with ALS should not have to wait for a proven drug until the end of 2017, or possibly not until 2018. It’s been 20 years since any kind of new treatment for this awful disease -- they’ve waited long enough.
Require full disclosure of all ingredients in disposable diapers for babies
We all know that most babies can wear disposable diapers and be just fine. Most babies do wear disposable diapers and are just fine. Unfortunately, some babies are not just fine. If you have one of these babies, your heart is probably pounding reading these words. If you don't, you don't. That's ok. You should still keep reading. You'll find this interesting. Product labeling laws generally ensure that you, the consumer, know what you're buying. Baby clothing is labeled. Baby care items are labeled. Baby food is labeled. No matter what, you get to know, before you buy it, if your baby's pants are cotton or polyester. You get to choose what your baby wears. You know, before you buy them, what is in your baby wipes. You know what is in your baby food. You have a choice. By contrast, your baby's disposable diapers are virtually unlabeled. No textile labels. No ingredient lists. No disclosure. Lots of secrets. Very little regulation. No required testing beyond basic CPSIA tests for lead & phthalates. And when you ask for detailed information about what is in the diapers your baby is wearing, disposable diaper companies don't have to tell you anything. If you ask about your baby's shirt, there are no secrets.If you ask about your baby's pants, there are no secrets.If you ask about your baby's food, there are no secrets.It's on the label. The law says it has to be.Because your baby is wearing a disposable diaper, there are secrets. Baby diapers are not considered medical devices by the FDA. Unlike adult disposable diapers, baby diaper companies are not required to go through medical device testing to prove that disposable baby diapers are medically safe for a baby to wear. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=876.5920 Baby diapers are not regulated as cosmetics by the FDA. Baby diapers may contain ingredients (like petrolatum, oils, or other lotions) that are cosmetic ingredients and may be intended to help prevent diaper rash, keep a baby's skin soft, or prevent contact with wetness. Baby diaper companies generally do not provide parents with a full, detailed, INCI compliant list of ingredients in disposable diapers. https://www.fda.gov/Cosmetics/Labeling/Regulations/ucm126444.htm Baby diapers are not considered clothing (garments) by the FTC. Specifically DISPOSABLE baby diapers are nearly the only thing worn by a human, other than a hat or a disposable menstrual pad, where product or package labeling isn't mandated by law to fully disclose the amount and type of materials used in the garment. Disposable baby diapers are one of the only garments worn by a baby not required by law to include care or content labels.https://www.ftc.gov/tips-advice/business-center/guidance/threading-your-way-through-labeling-requirements-under-textile#textile Why does this matter?Baby diapers are worn by babies, next to their genitals, for two to three years. Babies are exposed to everything in that diaper. Every fabric, woven or non-woven. Every chemical, intended or unintended. Nearly every other garment in our society has to be fully labeled. Everything. Even socks! Why aren't baby diapers fully labeled? Why don't we get to know everything our baby is being exposed to in a diaper? As a mom, you should get to know what is in your baby's diapers. If you want to avoid a certain ingredient, you should be able to avoid that ingredient. A disposable diaper is worn next to the skin and should be considered a garment. The composition of all textiles, woven or non-woven, should be disclosed on the packaging. If the diaper includes any chemical ingredients, a full INCI-compliant ingredient list should also be disclosed on the packaging. Babies are tiny with delicate, sensitive skin. Parents deserve to be active decision makers in their baby's care. Disposable diaper ingredients should not be kept secret from parents. What now?For your baby's sake, demand, today, that the FTC and the FDA eliminate product labeling exclusions for disposable baby diapers. Sign this petition. Tell them. #IGetToKnow what is in my baby's diapers.
Make Chronic Pain Patients exempt from CDC Guidelines
The CDC guidelines are causing doctors to leave pain management practice all over the US, for fear of DEA malicious prosecution if they exceed an arbitrary and unscientific “one size fits all” policy while trying to treat their patients effectively and as individuals. Patients are being deserted by their doctors, in some cases without assistance in drug withdrawal, after they have used opioids as directed, safely and effectively for years to maintain the quality of their lives. Almost certainly some patients have already died and more will commit suicide as a result. Our government is aware of this problem, but chooses to do nothing. The guidelines are also being embedded in State laws that reinforce restrictions on opioids. Major areas of several US States are now without pain management centers, and remaining specialists are seeing ever-heavier patient loads and higher risk of prosecution. The best predictors for people falling into addiction are their age (teens are particularly vulnerable), and their status as unemployed or poor. Restriction of opioid medications to pain patients won’t solve these problems. If anything, we should anticipate increases in deaths due to street drugs, as desperate people are forced to seek them out against their own wishes, just to maintain a marginal quality of life. The CDC needs to withdraw its unscientific and damaging opioid guidelines. Revisions should acknowledge that at the present state of medical knowledge, opioids are an indispensable part of managing agonizing pain, and trained doctors are the best decision makers on how much is needed to relieve pain in each individual patient. Standards of practice and doctor training are needed. But the present CDC guidelines are a poor basis for such standards. Re-writing should be accomplished by professionals who actually understand chronic pain and its management, and not by addiction specialists who have a financial self-interest in diverting limited government resources away from proven pain treatments. For the longer term, the US National Institutes for Health needs to allocate far more research and resources to the study and treatment of chronic pain. At present, less than 1% of NIH research funds are directed to chronic pain – for one quarter of the US population. The percentage of chronic pain patients who abuse their medication is less than 1%. There are well over 100 million people in the US suffering from some for of chronic pain. The only "epidemic" in this country is heroin and illicit fentanyl coming in from China and Mexico. Addicts are being catered to while the chronic pain community is suffering, turning to illicit drugs or committing suicide. It is time to STOP THE WAR AGAINST PAIN PATIENTS! We have rights too!
Mattie's Policy- Medicine For Mattie, for ALL.
Attention: I'm doing this for my friend and the future of our health care. Jaclyn White. We have a victory for Mattie. Now, can we please keep this going to make changes for all who are in need of medicine. Let's make a change in policy, by signing this petition. Don't allow someone behind a desk make decisions on your life!! Doctors need to have the final say and what is best for their patience. Please share.... Something has to give. No more taking whatever is handed to us. You PAY for insurance and yet we allow them to dictate what they will cover. Stop this kind of abuse of power from Insurance and pharmaceutical companies! Mattie's Policy- for ALL with and without insurance, that need treatment for their life. Dear Anyone Who Can Help, I am writing you on behalf of my 9 year old son Matthew. We call him Mattie, and we live in Newnan, GA. He is a smart, funny, stubborn, bright young man who loves playing video games, feeding and caring for his chickens, and helping his family. Mattie had a 2nd surgery to remove a dangerous spinal cord tumor from his spine at C3-C4 that was compressing his spinal cord. Unfortunately, Mattie suffered a spinal injury during surgery. He also had issues with his heart rate and blood pressure after surgery that put him in the intensive care unit at Children’s Healthcare of Atlanta at Scottish Rite. They stopped the surgery and were unable to remove all of the tumor. At that point keeping Mattie alive took priority over removing all of the tumor. Since then, he has had to undergo intensive rehabilitation at Children's Healthcare of Atlanta. He was unable to walk, move his left arm, or feed himself after surgery. Thanks to the Rehabilitation program at Children's Healthcare of Atlanta, he is able to walk short distances and is gaining back his endurance. However, his arm is still paralyzed at the shoulder. As proud as we are of our son, his battle is unfortunately not over. His team of experienced doctors want him to try an oral chemotherapy called Mekinist in order to attempt to shrink the tumor. However, the FDA has only approved it for melanoma. They want to do something called using this medication off label. There are no other chemotherapies available on the market that will help him. Because of the FDA labeling, our insurances will not approve the medication. His doctors are doing all they can to help him get the medication. Matthew has UnitedHealthcare as his primary insurance, CVS Pharmacy (Caremark) as his prescription coverage, and Georgia Katie Beckett Deeming Waiver Medicaid (Georgia Department of Community Health) as secondary insurance. The drug manufacture Novartis, is denying him patient assistance because he has insurance. The medication costs are 1/10 of the cost of what it will incur for the costs of his surgeries and rehabilitation. It's more cost effective and logical for Mattie to try this medication. If it shrinks these tumors, he will be able to grow up and become a productive, tax paying adult. If these tumors keep growing, he will become a ventilator dependent quadriplegic. The cost to the state of GA and federal government for his long term care will be astronomical. It's in everyone's economic best interest to try to help Mattie get access to this life saving and tumor shrinking medication. Also, the cold facts are, that if he has more surgeries, he is likely to suffer more spinal injuries and quite possibly not survive. I am begging you as his mom to help. If you can help influence anyone to approve this medication for my baby, I would be forever grateful. You have the power to help him if you so choose. His life, future, ability to walk and grow up, are literally in your hands. Please help us. You could quite possibly be his only hope. All I want for Christmas is for my baby to get a chance at being able to use this medicine. Respectfully,Katie McKoy
Make Ibogaine legal for opiate addicts
The heroin epidemic is out of control and we need solutions!!! Here's ours... My daughter was a $400.00 a day heroin/fentanyl user, using heroin for at least 4 years. When we almost lost her I decided to get angry. Angry at the drug that is. I started talking about it and searching for a way to save her. One day I was in a business meeting when her ex-boyfriend walked in and simply asked how she was. After a rather embarrassing cry I had to give an explanation and one of the gentlemen asked if I had heard of Ibogaine. Of course I hadn't so he shared what he knew, he had heard of it on Law &amp; Order of all places! Grasping for any chance to save my daughter I started researching, talking to friends in the medical field and a company that sells Ibogaine. It seemed too good too be true, even with the risks. My daughter had sepsis and was close to death when she was dropped at the doors of the local hospital by her "friends", and without this treatment she would not be here! **I'm going to leave a little of the story out here aka plead the 5th** When my daughter took the Ibogaine we were naturally nervous because ultimately it was a drug, so the plan was to go directly to the ER. Luckily the nurse on duty had experience with the treatment because a doctor she had previously worked with recommended Ibogaine to his patients. The ER doctor on duty had the nurse call poison control and imagine our relief when they said they have seen no serious adverse effects from this treatment and only recommended fluids and monitoring. Now the results have exceeded my every hope for what this treatment would do. Simply amazing! She woke up the next day euphoric. Looking into a mirror she asked me if she looked different, and I could see that she certainly did in her eyes. She was really seeing herself for the first time, that is a feeling I will never forget. My daughter has no withdrawal symptoms, no cravings, stopped taking anxiety and depression medications. She processes information differently than before treatment, sees the world a little brighter and herself clearer. If I'm being honest I wouldn't mind a little of that treatment myself!! Here's the email address for Office of National Drug Control Policy. Have any thoughts on heroin? Pass them along!!! email@example.com
Stop Making Chronic Pain Patients Suffer
My name is Ashton Smith. I deal with chronic pain every single day of my life. Pain medication helps me live a semi normal life but the war on opioids has done nothing but harm people like me. The DEA has doctors afraid to prescribe anything for people in legitimate pain for fear of the DEA: who threaten their licenses. Everyone keeps asking for harder laws due to the heroin "epidemic" but this epidemic is caused by the harsh 2014 rescheduling of opioids. People in chronic pain are resorting to heroin or suicide because no one is treating their pain. Multiple studies have shown people with chronic pain rarely abuse their medication. We ask the DEA to think of us when you make it harder for us to function. Allow doctors to BE doctors & stop the war on chronic pain patients
Stop promoting lung cancer stigma in the media
For years, anti-smoking ads effectively reduced smoking by emphasizing negative images of smokers afflicted with lung cancer. Unfortunately, these ads caused the public to equate smoking and lung cancer, and villianized smokers and lung cancer patients instead of tobacco and tobacco companies. This "smoking equals lung cancer" meme is persistent, pervasive, and generates lung cancer stigma. Lung cancer stigma increases depression and blame among patients and their family members, reduces compassion and funding for lung cancer, hinders awareness of other lung cancer risk factors, and discourages those at high risk from seeking lung cancer screening that could save their lives. The "smoking equals lung cancer" meme is unfair and inaccurate. The Centers for Disease Control and Prevention (CDC) and the National Cancer Institute (NCI) state smoking affects every organ in the body and is a risk factor for twelve cancers as well as sixteen other diseases, including heart disease, the biggest killer of all. In fact, more people die of smoking-related cardiovascular disease than die of lung cancer. But publications and media usually mention smoking and smoking cessation only in association with lung cancer. This reinforces the stigma. What do we want?We're asking US and global cancer organizations, media companies, researchers, and professional organizations to help reduce lung cancer stigma by reducing the "smoking equals lung cancer" mindset. We're asking they do this by using the following tactics in their communications: avoid using any images of tobacco products in communications about lung cancer refer to smoking as a RISK FACTOR for cancer (instead of a cause) when discussing smoking in association with lung cancer, include references to other known risk factors for lung cancer avoid featuring communications about smoking and smoking cessation in proximity to lung cancer communications whenever possible discuss smoking and smoking cessation in association with EVERY cancer (not just lung cancer) and every disease linked to smoking Why do we care? Lung cancer is the most deadly cancer. In the US alone, a jumbo jet's worth of lung cancer patients die every day. One in sixteen people in the US will get it in their lifetime, and about 80% of them will be nonsmokers. Organizations that promote smoking cessation focus on lung cancer patients (most of whom do not smoke) rather than ALL patients whose diseases are linked to smoking. The fact is, smoking cessation cannot cure ANY cancer, nor guarantee a person will not get lung cancer. Because of stigma, many people don't know that anyone with lungs can get lung cancer, and that lung cancer research is funded at a level far less per death that other major cancers. Members of the Lung Cancer Social Media (#LCSM) community want to change these facts in our lifetimes. You can learn more about lung cancer stigma here https://lcsmchat.com/lung-cancer-stigma-references/Supporters of this petition include [names of lung cancer organizations]
Legalization of Marijuana
This petition supports the legalization of marijuana. This document will inform citizens and the government on how the benefits of legalization will prevail the disadvantages. Legalization of marijuana will not only boost our economy but can also affect people’s choices on how to use this drug properly to avoid complications. The legalization of marijuana is a pressing point in question. Fifty-two percent of Americans over eighteen have tried marijuana at some point in their lives. Why has the government not taken advantage of this economic prosperity? Cannabis/Hemp can be the largest cash crop since cotton and legalization can lead to a boost in the economy and create American jobs. Colorado has brought in nearly $73.5 million in selling marijuana and marijuana-related products in just a few years. Creating jobs and increasing cash flow is one of the many reasons why recreational marijuana should be legal. Many accept different views on how marijuana can or cannot be harmful. An estimated 88,000 people (approximately 62,000 men and 26,000 women) die from alcohol-related causes annually, making alcohol the third leading preventable cause of death in the United States. The first is tobacco, and the second is poor diet and physical inactivity. On the other hand, marijuana can cause lung cancer, psychiatric events, serious cerebral and cardiovascular complications. I do not believe the claim that no one has ever deceased from consuming cannabis. The more serious complications of marijuana, however, are rare. Who is most likely to experience these serious complications? According to drugabuse.gov, marijuana’s effects on a person depends on a number of factors, including the person’s previous experience with the drug or other drugs, biology, gender, how the drug is taken, and the drug’s potency (its strength). If marijuana is legalized, the government can control three of these factors: the person’s previous experience with the drug or other drugs, how the drug is taken, and the drug’s potency (its strength). The government can monitor dispensaries by monitoring the potency of products, putting an age limit on who can buy from dispensaries, and lastly what kind of marijuana products they sell. The federal government will benefit from the legalization of marijuana due to increase control over the marijuana business. Not to mention, doctors prescribe marijuana as a medication to patients with cancer, chronic seizures, nausea, Alzheimer's, and HIV/AIDS. The list continues on conditions in which marijuana can be prescribed.If you agree with these reasons on why marijuana should be legalized please sign this petition.
Remove the DEA's classification of CBD oil from marijuana as a schedule 1 drug
The DEA has officially announced that it has classified CBD oil specifically from marijuana as a schedule 1 drug. This is an outrageous scheduling of this drug that has helped to save so many lives and CBD continues to do so. CBD is also non-psychoactive. This means it does not get you high. The DEA seems to not take into consideration. The public is screaming out for massive change but this change is a complete 180 in terms of progress in cannabis legalization. I need your signatures to force this change. Its simple but can make the change we desire. For clarification the CBD extracted from Hemp is legal. Let me cite some sources for you. Hemp Products Heal Ben Swan Reality Check What is CBD? So DEA... What is your legitimate reasoning as to why you have scheduled this as a schedule 1 drug with no medicinal benefits and highly addictive? It has been proven time and time again that these are lies. You want to suppress this plant. Your desperate. We see it. You cannot win. Take cannabis off drug scheduling. Hundreds of thousands of people's lives will be saved or dramatically improved with the re-introduction of cannabis and hemp. Please sign this petition.
Approve Umbilical Cord Stem Cell treatment for Jacob Gallegos in California
Jacob Gallegos has lived his 32 years of life with a debilitating and deadly disease called Duchenne Muscular Dystrophy (DMD). DMD is a common progressive genetic disorder, which causes aggressive deterioration of the muscles. Patients with this disease typically do not live past the age of 27. Jacob is a fighter but he needs your help. Jacob relies on a tracheostomy tube for breathing and a G.I. tube for eating and fluids. He is not able to drink water or any beverage at this point. He dreams of being able to swallow again one day and enjoy a glass of ice cold water as well as regain the use of his arms. He can only move his fingers and toes. As the disease progresses he won't be able to use his fingers which will leave little hope of connecting to friends on social media or creating his digital artwork. These are the final freedoms he has left in life. There is a treatment available that has proven to extend the life and quality of life for those granted the right to have this treatment. There have been two DMD patients who have had umbilical cord-derived stem cell treatment for this disease in the United States, Ryan Benton, and the latest patient, a 6 year old boy. Both patients travelled to Panama for the initial treatments, as there are laws restricting adult stem cell therapy in the United States. The FDA has approved subsequent treatments to be administered in the United States, but only for these two patients. Ryan Benton's condition has stabilized and he has suffered no adverse side effects. His prognosis has gone from critical to stable. His quality of life has improved greatly, gaining weight and muscle control back. Jacob cannot travel to Panama to receive this treatment and without it, his prognosis is very poor. His condition is critical and it's imperative that he begin some form of treatment as soon as possible. Imagine what it would be like to be a cancer patient, and the treatment needed was available, but only for two patients, leaving you only one outcome and that is to die. Jacob deserves to live! Jacob deserves treatment! Tell the FDA to make this treatment available for Jacob, in California.