Food and Drug Administration
Food and Drug Administration
Please ban torturous shock devices used on special needs people
UPDATE: Until May 25 the FDA is accepting public feedback on banning the use of shock devices on people with disabilities. After signing this petition, please leave a comment with the FDA here: http://1.usa.gov/1TS5jwL (read the summary then click the blue Comment Now! button). I deeply regret working as a teacher’s assistant at The Judge Rotenberg Center (JRC), a “special needs school” in Canton, Massachusetts, where children and teenagers with autism and other disabilities are administered electric shocks as a means of controlling their behaviors. I joined the JRC because I thought I would be helping these special needs students. But it became clear that this practice was painful, traumatic, and more harmful than good. I never would have used these "GED" shock devices had JRC not told me and other staff in training that they had been “approved by the FDA”. When asking an administrator about the severe thick and bloodied scabby injuries all over students' bodies, I was told that these machines had been tested and were “proven to be safe." I did not know until 2012 that this was a lie! The human rights abuses taking place at the JRC are well documented. In 2013, the United Nations in “Report of the Special Rapporteur on torture and other cruel, inhuman or degrading treatment or punishment, Juan E. Méndez,” unequivocally stated that the methods used at the JRC are “torture” in violation of international human rights standards. On my petition you can watch a short video of Andre McCollins strapped down on a restraint board by lock and key, and shocked repeatedly over seven hours. It's hard to watch but the video shows Andre, who has autism, being being shocked for refusing to take off his coat. He was embarrassed that he had been forced to wear the clothes of another student that morning that he was concealing with his jacket, and people with autism sometimes have difficulty with change. Andre was shocked an additional 19 times that day for tensing his muscles while being tortured (tensing muscles reduces the amount of pain), and he was shocked 9 times for yelling and screaming for the shocks to stop, all in response to being shocked. JRC listed "full body tense up" as a "health dangerous behavior", and yelling and screaming - "Someone, help me, please!" as a "major disruptive behavior," even though Andre was strapped to the board as this was happening! The treatment that Andre received was not unique. JRC's lawyers testified in court that staff did their jobs well that day by following Andre's program. While I was an employee at JRC, I observed many students being tied up on restraint boards and restraint chairs and shocked repeatedly. In some rooms, three students might be tied to restraint boards getting shocked at the same time. The lower-functioning nonverbal students were often shocked up to the maximum of 30 shocks per day, resulting in so many bloody and crusty scabs all over students' arms, legs, torsos, and fingers, that there was nowhere left to place the electrodes without burning through old scabs and burns. Students at JRC are not only shocked for severe behavior problems. I was forced to shock certain students for even the most minor behaviors such as pulling apart a loose piece of thread, tearing a used paper cup, standing up to give a teacher a hug, or standing up and raising a hand politely to ask to go to the bathroom. Many of the lower-functioning nonverbal students lived and reacted in constant fear and anxiety. When they observed their peers being shocked, and even when they saw a teacher reaching for a pencil in their pocket that was close to the remote control buttons that activate the shock devices, these students in their extreme anxiety would stand up out of their seat, yell in fear, throw down their task, or pull their own electrodes off of their skin -- and are then shocked for these reactions. A young man with autism was shocked for closing his eyes for more than 10 seconds while sitting at his desk. As part of her behavioral plan, a beautiful nonverbal blind girl with cerebral palsy was shocked for attempting to hold the hand of any staff, which was her only means to communicate and to be loved. The same student was also shocked according to her behavioral plan for "loud moaning," and later it was discovered she had a cracked tooth and that her loud moaning had been her many attempts to communicate that she was in severe pain! In 2006, the New York State Education Department (NYSED) wrote a detailed report that included descriptions of highly abusive and questionable interventions (which have not been systematically studied and have not been reported in the empirical literature) against New York State students, but was unable to pull students out of the JRC due to the threat of costly litigation and to JRC’s deliberate misleading of New York State authorities. In 2011, Dr. Matthew Israel, the founder and the Executive Director of the JRC, was indicted by a grand jury for the obstruction of justice by destroying evidence related to the use of his GED-shock devices, which had caused severe injuries to students. The plea agreement reached with the Commonwealth of Massachusetts resulted in his resignation (he now resides in California), and five years’ probation. Parents of students still at JRC and certain state authorities are misled to think that only severe pain and torture can help their children. Schools exist across the country and globe that serve students who have very similar needs to students at JRC. Students at JRC are not unique to the rest of the world, but only JRC specializes in severe pain and acts of torture. Already New York State has returned some of its students to New York from JRC. Please ban all aversive shock devices in America and bring America into compliance with the United Nations Universal Declaration of Human Rights, Article 5: “No one shall be subjected to torture or to cruel, inhuman or degrading treatment or punishment.” How can America ask other countries to comply with the Universal Declaration of Human Rights if America does not also comply?
Tell the FDA to stop denying ALS patients treatment options
When I became a parent, I knew immediately that I would do anything to protect my daughters from the hardest parts of life. My mission would be to give them as much love and comfort as I possibly could. But now instead of me taking care of them, my daughters are often responsible for taking care of me, because in May of 2014 I was diagnosed with ALS. Now, instead of protecting them, my daughters are forced to watch as my body dies one muscle at a time. ALS is a devastating disease, that currently has no effective FDA approved treatments. However, there are promising therapies in the FDA approval pipeline that might improve my chances and quality of life, but the FDA isn’t willing to expedite the approval of these drugs, even though the average life expectancy of an ALS patient is 3-5 years and the average time it takes for a drug to become FDA approved is over a decade. Please join me and Hope NOW for ALS in petitioning Congress and the FDA to apply Accelerated Approvals (AAP) to promising treatments targeting terminal diseases, and implement faster, smarter, and more humane clinical trials using today’s science. This is not a radical or new idea. In 1992, in response to the HIV/AIDS epidemic, the FDA adopted the Accelerated Approval Program (AAP) – an expedited approval process to treat fatal diseases. This was a process to allow patients fast access to potentially life saving drugs, and has since been used for cancer and heart failure treatments. But the FDA refuses to apply it to ALS and other rapidly fatal diseases. How can it possibly be fair to exclude the most vulnerable and at risk people -- those with fast acting terminal diseases -- from this program? ALS is always fatal, and there are currently over 30,000 patients in the US with no options. We need help. We need options. My diagnosis is the greatest challenge my family has ever faced, and my daughters have amazed me with their grace and strength in taking on this battle with me. I know that even though my life has not turned out like I imagined it, I can still be the dad I always wanted to be, and I can still show my daughters what it means to take a stand for what counts. Please join me and Hope NOW for ALS to help save my life, and the lives of so many others around the country.
ALS patient access to Brainstorm's treatment NurOwn
My name is Bobby Forster and I have ALS, also known as Lou Gehrig’s disease. Most people with ALS live 2-5 years after their first signs of disease and our treatment options are limited.Recently, I was a participant in the US trial of a new treatment called NurOwn. After two weeks of treatment I went from barely able to stand for more than ten seconds, to being able to walk with a walker, to being able to walk unassisted. I also saw significant improvements in my forced vital capacity (FVC) and speech. Other participants yielded great results as well.My improvements continued for a month, then my progression plateaued for a month before I began progressing again. This therapy is one that will require multiple treatments every couple months. Unfortunately, the company that makes NurOwn, Brainstorm, is hesitant to pursue accelerated approval of this treatment with the FDA and has opted to conduct a Phase III trial which could delay approval for another 5 years. Without accelerated approval thousands of ALS patients could die over the next several years waiting for the traditional process for approval to be completed. Another challenge Brainstorm faces is raising enough money to conduct an expensive Phase III trial. If the money is not raised then Brainstorm and NurOwn could be dead in the water and the treatment will never make it patients. This treatment has now been in multiple trials both in the US and Israel. It has been shown to be effective and has no significant side effects. It is time for all ALS patients to gain access to this ground breaking treatment. Please sign this petition and ask Brainstorm to pursue accelerated approval of NurOwn with the FDA. I am sick and tired of seeing my friends die while there exists a safe and effective treatment.
FDA: Ban Torture of People with Disabilities and #StopTheShock
The Judge Rotenberg Center (JRC) in Canton, Massachusetts is a “treatment center” that uses their own, non-FDA approved electric shock devices on disabled people, primarily autistic people with and without intellectual disabilities, as a way of controlling their behavior. Children and adults at the JRC wear shock devices all day and staff of the facility deliver painful electric shocks remotely. It is the only program in the U.S. that uses these devices as punishment. The United Nations Special Rapporteur on Torture determined that the use of these devices is not treatment -- it is torture. In 2012 the American public became aware of what was going on inside JRC when video of Andre McCollins being shocked was released. Andre was a teenage resident of JRC. In 2002, he one day refused to take his coat off. The staff responded by placing Andre in restraints for 7 hours and shocking him 31 times. After this torture, Andre was in shock, comatose, and suffered burn wounds on his arms and legs. The trauma that he went through continues to negatively affect his mental health to this day. In 2014 the FDA held hearings about these devices. In April 2016 it drafted regulations to ban contingent shock -- but it has not implemented them. It is time for FDA to release the regulations. What happened to Andre McCollins is not an isolated incident at JRC. The Judge Rotenberg Center claims that the electric shocks keep people from hurting themselves or others, but residents at the JRC are shocked for everything from swearing to standing up. Furthermore, electric shocks do not work to help people with disabilities avoid self-injury or aggression -- positive supports do. For every person being tortured at the JRC, there are many more people with the exact same disabilities, dealing with the exact same issues, being successfully supported in their communities without the use of dangerous and painful punishments. The worldwide autistic community and our allies call on Scott Gottlieb, Commissioner the U.S. Food and Drug Administration, to immediately ban the use of contingent electric shock in behavior modification. Additionally, we call for the state of Massachusetts to immediately shut down the Judge Rotenberg Center (JRC) in Canton, Massachusetts. Shock torture is only one of the abuses at JRC. It needs to be closed entirely, and appropriate services created in its place. All people have the right to freedom. This includes autistic people. The United States and the State of Massachusetts must protect those rights. Stop the shock, close JRC, and provide our people with the supports they need. Please sign this petition.
Food and Drug Administration: Approve the OnCoBlot test for cancer diagnosis
My name is Lori, and I’m on a mission to make cancer diagnosis more affordable and less fear-inducing than our current methods. This is especially important for people who have a history of cancer within their families and people who’ve successfully treated their cancer in the past. Cancer survivors in particular should have a comfortable and inexpensive method to monitor their health status. Right now, the most common way to screen for various cancers is by using nuclear imaging technologies such as MRI or PET-CT scans. These tests are expensive and invasive -- often requiring injections to prepare the body’s tissue for imaging. A less invasive and less expensive alternative to these scans is the OnCoBlot test. This blood serum test helps identify up to 25 different cancers with a single test and it is 96% accurate. Because the test hasn’t been approved by the FDA yet, it isn’t covered by most health insurance. That’s means a patient would have to pay out-of-pocket to receive it. But the out-of-pocket cost of $800 - $1000 is still far less expensive than an MRI or PET-CT scan while being equally accurate. Please sign and share this petition to tell the FDA that cancer patients and cancer survivors deserve access to safe, accurate, cost-effective cancer diagnostic testing.
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/
Ban mercury dental fillings in children like the European Union did!
Dental amalgam – a filling material for cavities deceptively marketed as “silver” fillings – is about 50% mercury, a neurotoxin. As of 1 July 2018, the European Union has banned amalgam use in children under age 15, pregnant women, and breastfeeding mothers. In stark contrast, the U.S. Food and Drug Administration (FDA) has done nothing to protect these most vulnerable populations...or anyone else. In its amalgam rule, FDA concedes that this mercury product poses a risk for the unborn and young children: “The developing neurological systems in fetuses and young children may be more sensitive to the neurotoxic effects of mercury vapor.” FDA also admits that there is no scientific proof that amalgam is safe for these populations: “Very limited to no clinical information is available regarding long-term health outcomes in pregnant women and their developing fetuses, and children under the age of six, including infants who are breastfed.” But while the European Union is making sure its children get modern mercury-free fillings, FDA’s amalgam rule continues to promote using this toxic mercury product in American children. It's time for FDA to ban amalgam use in children under age 15, pregnant women, and breastfeeding mothers. All children deserve the same protection from mercury fillings as European children!
Horseshoe Crabs are important, stop bleeding them dry: Find the Solution to Synthetic LAL Now!
I am known on Tumblr for my post about the importance of the Atlantic horseshoe crab--100,000+ shares strong. But the importance of these incredible creatures cannot be captured in a few words on a social media website. The Atlantic horseshoe crab (Limulus Polyphemus) is considered by scientists to be a "living fossil," it is one of the only organisms that has survived without evolving since the age of the dinosaurs, 450 million years ago. They are also known as helmet crabs, and they are actually not all that closely related to crabs at all--they are genetically more closely related to spiders and scorpions, and they crawl around the surface of the ocean when they're not spawning on the shores of the East coast--most prominently on the Jersey Shore, Long Island, and Delaware, and even in the Gulf of Mexico. Aside from their entire existence and history being prehistoric, so are their immune systems! Horseshoe crabs bleed blue (no, literally) because their blood is mostly made of copper--unlike that of humans--our blood is composed mostly of Iron. Their blood, along with their really neat prehistoric immune system, contains a substance called LAL (Limulus amebocyte lysate), which coagulates around endotoxins and bacteria, detecting their presence. Since 1970, every pill, medical instrument or other tool used and approved by the U.S. Food and Drug Administration has undergone testing using horseshoe crab blood, which costs around $15,000 per quart. These critters are super important to our health, but what about their health? When we extract their blood, we take around 1/3 of their blood cell count, and due to the old-fashioned nature of their circulatory system, it can take around 6 months for a single horseshoe crab to restore itself to its normal blood cell count levels. During the process of their "donation" to American medicine, it is estimated that 18% of horseshoe crabs die from blood loss and other complications related to the extraction process. While it is technically illegal to bleed the same crab twice (which is why they are often tagged by medical companies, to ensure that they don't re-collect that same crab,) it is still cruel to be taking these animals away from their homes and habitats, bleeding them out and leaving them to re-adjust their blood cell count. Their prehistoric immune systems and body processes cannot handle this, and because of this, their population remains in great danger. Our scientific research and advancements in technology could certainly afford to find a synthetic solution to LAL. The health industry knows the chemical composition of horseshoe crab blood, so why can't they make a synthetic version? If they can afford dozens of quarts of copper-based blue blood, they can afford a synthetic alternative to bleeding these friendly, awesome creatures dry. I am urging you to sign this petition to ask the FDA and the EPA to work together to minimize the amount of horseshoe crabs who are bled annually, and to work more quickly and efficiently toward finding a synthetic alternative to horseshoe crab blood/LAL. Horseshoe crabs are not only a really cool connection to our prehistoric past, but they are friendly and wonderful animals who contribute great things to our aquatic ecosystems. For more information, please visit the sources below. Sign and share! Thank you, Caitlin O'Connor Sources: http://www.pbs.org/wnet/nature/crash-a-tale-of-two-species-the-benefits-of-blue-blood/595/ http://www.cnn.com/2014/09/04/health/this-crabs-blood-could-save-your-life/ http://www.ncbi.nlm.nih.gov/pubmed/20593268 http://www.horseshoecrab.org/med/med.html
Let the White House know Kratom leaf is safe and should remain as a dietary supplement.
We are petitioning today in regards to the FDA’s public health advisory related to their mounting concerns regarding the alleged risks associated with the use of kratom, a traditional tealeaf in the same family as the coffee plant. The agency’s two main concerns that this advisory focuses on are poison control center calls, increasing 10-fold from 2010 to 2015, and 36 deaths “associated” with kratom. This letter considers these concerns, puts them in perspective to other commonly used substances like energy drinks, and presents sound scientific evidence that was submitted to the DEA, FDA, as well as members of Congress and the U.S. Senate in 2016 showing that kratom tea is safe and poses little to no health risk to Americans nationwide. We will also cover mutually beneficial manufacturing practices and standards that have been adopted by the kratom industry that would alleviate any compliance issues, and ensure continued safe use for the millions of Americans that enjoy this celebrated traditional tea. As recent as the Fall of 2016 the DEA brought up the same concerns that the FDA has now, but sought a much more aggressive approach by attempting to emergency schedule kratom tea through the Controlled Substances Act. This was the first time a natural tea was targeted in this fashion, and Senator Orin Hatch along with 8 other U.S. Senators and 51 U.S. Representatives advised the DEA to consider consumers, researchers, health professionals, law enforcement officials, and other stakeholders to allow a more fulsome decision. This opened a six-week public comment period that resulted in an overwhelming 23,023 Americans (99.1%) submitting comments during the DEA’s 6-week comment period favoring to keep kratom legal. Only 113 people (0.49%) were for banning kratom. If it were as “deadly” as the FDA says it is, wouldn’t at least 1% comment to ban it? The FDA claims Poison Control Center calls increased 10 fold from 2010 to 2015 but neglected to report the actual call numbers or put them in perspective. The agency is citing a July 2016 study by the CDC that states the calls were at 26 in 2010 then 263 in 2015. Out of 323.1 million Americans only 263 calls were made to poison control centers while in 2014 energy drinks received 5,156 calls with more than 40% of those calls involving children younger than 6, with some suffering cardiac and neurological symptoms. Scientific research, expert testimony, and Poison Control data have shown that kratom tea is far less dangerous than these common substances that pose serious health risks to Americans and our nation’s youth. The agency uses the term “associated” when describing the 36 deaths because kratom was not the sole cause of death when in fact no deaths have ever been attributed to kratom alone. This numbers pales in comparison to 34 deaths attributed to energy drinks in 2014 alone. In all kratom cases individuals died while taking prescription drugs and other substances, some even of natural causes, but happened to have been taking kratom at the same time. This issue was of great concern to the state of Florida and was addressed by the Florida Department of Law Enforcement Commissioner Rick Swearingen with the Office of Statewide Intelligence in 2015. Their investigation concluded, “A review of available law enforcement and laboratory sources in Florida demonstrates that Kratom does not currently constitute a significant risk to the safety and welfare of Florida residents. According to the Florida Department of Health (DOH), no pervasive health issues have been attributed to the ingestion of Kratom products in Florida.” This subject has also forced independent studies by revered scientists like Jack Henningfield PhD of Pinney & Associates, one the world’s leading experts on addiction and safety. He states, “This is a remarkable record of safety and low abuse risk for any substance used by millions of Americans, as described by other witnesses in this hearing, and it is especially remarkable for a substance with some opiate-like pharmacological activity.” The beneficial potential, safety, and efficacy of kratom tea has been discussed, studied, even clinically researched and found to be as safe as coffee, its close relative, with several NIH funded studies conducted, some of which are still ongoing within the last few years. In recent years the kratom industry has labeled all products for adults 18 years of age and up, adopted FDA labeling standards, analytically tests kratom leaf with state of the art technology, as well as recommending reasonable and safe dosage, while manufacturing in American made GMP facilities. Given the facts there is more than enough research and evidence in support of kratom being a safe herb that millions of Americans use to support their health and overall well-being. Please urge the FDA to reconsider their stance and take a closer look at the facts and science that is still fresh from last year. We sincerely appreciate Commissioner Gottlieb’s concern but we need not repeat that past so quickly.
Reduce drug waste and environmental hazards by changing FDA drug expiration policy
Every year, drugs that have reached their published expiration dates are thrown away, creating billions of dollars in waste and causing an environmental hazard. Multiple researchers and the US military have proven that drug expiration dates can be extended safely. There is no recorded case of a patient being harmed by the use of an expired drug. The pharmaceutical companies set these expiration dates to increase revenue and not to protect the public. It is time for the FDA to create a new policy and testing requirement for drug expiration dates in the United States that is good for the people and the environment! See our presentation on this subject https://drive.google.com/open?id=16WvhICqJfGcvsL4QrkXNm5h-Qt3yDgQQ