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!
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]
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
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.
Charge Heroin Dealers With Murder
I am trying to solve the heroin epidemic that has embraced our country. As it is portrayed, heroin users are "sub-human" - not worthy of life itself- that disgusts me- I lost my daughter and she was no way near sub-human. She was your daughter too- your son, mother, cousin, father.. she was a PERSON.. not someone who deserved to die. Heroin dealers are at least 50% responsible- if not more. I have seen first - hand the influence of a dealer, they know they will have an addict for life - a constant flow of money/ a customer. I know first hand how dealers charge their "addicts/customers" double if they can pay "today" because they know that once they are addicted- they got them. They are pushing and selling for financial gain.. only. I also know federal statutes exist to charge dealers with murder. Why are some law enforcement charging while others are not ? If these laws were consistent in every state it might eliminate the dealers- right now there is no fear of murder or manslaughter charges. The dealers know they will not be charged and will not do any real time. Only trafficking charges but not murder. Why cant we change that? These laws exist.. what do we have to do to enforce them? https://www.dea.gov/druginfo/ftp3.shtml
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
Change current CDC guidelines for chronic pain sufferers
The CDC changed the guidelines for opioid pain treatment in 2016 without consulting the public or the FDA. The FDA is the only government agency that can pass regulations on the use of prescription medications.Millions of Americans suffer from some form of Chronic Pain Syndrome. If you are not a CPS sufferer chances are you have a family member or friend who is. How might this effect Non- CPS consumers? What is to stop the CDC, FDA, or DEA from deciding one day that muscle relaxers, antidepressants or seizure medications are being overused and/or abused? This is not impossible. Each of these classes of drugs are also used to treat chronic pain. THIS IS NOT JUST MY STORY BUT ALSO THE STORY OF MILLIONS OF OTHERS. In 2003 I had a household accident. I was treated with hydrocodone for the acute pain. However, 6 months later I still had the pain but in more places in my body. It took 5 more years of doctors and specialist to finally get a reason for the pain. Fibromyalgia. By that time I was put on a maintenance dosage of Oxycontin ER (extended release) and my life became functional again. I still had days when the pain was unbearable but they where few and far between. In 2013 I developed polyneuropathy from being a diabetic. I began taking Lyrica. In 2014 I was finally referred to a pain management clinic. They made me start from the beginning. I had to go through every non-narcotic pain treatment for 3 months to see if it would manage my pain. Of the 11 different medications; six did nothing for my pain and the other 4 I developed severe allergic reactions to. Ah ha, so it back to the Oxycontin ER. Finally life begins to look up again. I had 4 months of a functional life back. In June 2015, after getting my monthly prescription for the Oxycontin, I was told my insurance would no longer pay for it. My sole source of income being SSI, I did not have $385 to fill the prescription. I called my pain doctor and he tells me he wondered if the insurance would pay. Apparently many of his patients were having the same problem. Now it is Oxycodone for the pain. What I discovered about the difference between extended release meds and immediate release meds is this; extended release will actually work for 10 to 12 hours whereas immediate release meds (especially narcotics) last about 3 to 4 hours but you can only take them every 6 hours. So much for my functional life. This went on until August 2016. By then everyone in the CPS society knew the CDC was on the warpath about Oxycodone. Too many people in West Virginia were killing themselves taking the stuff. It did not matter that most of those people did not have either a prescription or legitimate pain problems. In August of 2016, at my usual monthly pain clinic appointment, my pill count came up short. Every month you have to bring in your prescription bottle so the medical staff can count them. It was their way of dealing with abusers. The prior 3 weeks I had had a significant jump in my daily pain levels. I called the doctor and let him know the usual 60 mg per day was not helping at all. I was told I could increase my daily dosage by one 10 mg pill. So I did. End of the line, you are now a drug seeking junky. That was how I was treated. No more pain meds and no need to make another appointment. This is the standard practice if you are short on your pill count. I sat there in shock when I was told this. I did not count the pills myself. I was allowed just enough oxycodone to get me through the withdrawal period. I went to my primary care doc and she put me on a drug that is supposed to suppress the urge for narcotics and relieve pain. I spent 5 days in hell going through oxy withdrawal. All I got out of 4 weeks of use were blisters in my mouth, horrible diarrhea and stomach cramps and a boat load of pain. Can I get back on the oxy now I asked her. NO. You are an addict and I cannot give an addict narcotics. It took six weeks before my rheumatologist finally took pity on me and gave me a script for oxy. The type of treatment, I described above, is widespread throughout this country for anyone suffering from chronic pain. Not every chronic pain sufferer is an addict. I am asking you to email your congressional representatives, call the CDC and FDA. Tell them that the new "guidelines" are cruel and inhumane.