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 Ban Harmful Synthetic Food Dyes
A number of studies -- and an emerging scientific consensus -- demonstrate that some children experience episodes of inattention, hyperactivity, and other harmful behavioral effects following exposure to synthetic dyes. Many of these dyes, including Red 40, Yellow 5, and Yellow 6, require warning labels in Europe because of adverse health effects. Yet the Food and Drug Administration (FDA) has failed to act to ban these cheap, synthetic chemicals with no nutritional or essential value from food. Please sign our petition asking the FDA to ban synthetic food dyes in the United States, and, in the meantime, to require a warning label on dye-containing foods and beverages. Thousands of parents of affected kids confirm these findings and have sent our organization emails detailing their families’ struggles to identify that dyes are the cause and help their children. These dyes are sold in products like Fruity Pebbles, Hawaiian Punch, Kool-Aid, and many others lining the shelves of grocery stores. We need members of the public to tell FDA to ban dyes and, in the meantime, to require a warning label on dye-containing foods and beverages to let parents know of the issue. Given how widespread dyes are in food, public pressure on the FDA and companies that use dyes is the best way to win this fight. Consumers have used Change.org and other social media channels to successfully communicate these concerns to major companies, and as a result of this advocacy Kraft removed artificial dyes from Mac & Cheese products, Taco Bell and Panera eliminated these dyes, and General Mills and Mars announced they’re doing away with them as well! Banning dyes is an achievable step that will improve the safety of the food supply, and we believe members of Congress and consumers will be able to successfully pressure the FDA to take decisive action to remove these dyes from our food system. In Europe, most synthetic dyes dropped out of the food supply after the European Union required a sensible, clear warning notice on foods containing dyes, based on studies done in the United Kingdom that showed the harmful effects of dyes on kids. Yet many companies that removed dyes from foods in Europe continue to sell the same foods in the United States with the artificial dyes still in them! As detailed in our recent report, Seeing Red: Time for Action on Food Dyes, studies show that susceptible children—which may number more than half-a-million in the U.S.—experience episodes of inattention, hyperactivity, or other behavioral effects, after consuming foods containing synthetic dyes. In addition, recent research has revealed far higher levels of dyes in commonly consumed foods than was previously thought. Please sign our petition and share it with your family and friends.
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.
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/
Stop discriminating and screen male blood donors equally
The FDA recently announced that gay and bisexual men might finally be allowed to donate blood after being banned for life since the ‘80s — but only if they are celibate for one year. So straight guys can have safe sex with woman after woman and still donate blood. But gay and bi men who have safe sex for an entire year – even with a monogamous partner – would still be banned. Sounds like discrimination to us. We want the FDA to screen all prospective blood donors based on risk, regardless of their sexual orientation or gender identity.
Allow access to epinephrine without a prescription
In October 2014, my 18-year-old son Dillon was finishing up yard work with a friend when he was stung by a bee. He didn’t know what happened, but he started to feel very ill. His friend called 911 and administered CPR until help arrived. By this time, Dillon's heart had stopped beating and he needed to be defibrillated. Dillon fell into a coma and passed away the next week from a fatal allergic reaction. He’d never been diagnosed with an allergy, so he wouldn’t have ever received a prescription for epinephrine, a drug that could have stopped the reaction and saved his life. Unfortunately, the U.S. Food and Drug Administration (FDA) currently mandates that an individual can only access epinephrine with a prescription, so it is not readily available in cases of emergency. It breaks my heart that I couldn’t do anything to help my son after he was stung. Dillon was so outgoing, passionate and friendly -- he could walk into a room with 100 strangers and walk out with 95 new friends. He was going to do great things in this world. But such greatness was gone in no time because a prescription is required by individuals to access potentially life-saving epinephrine. Tragedies like Dillon’s passing can be largely preventable with greater access to epinephrine. That’s why it’s vital that we convince the FDA to change how it classifies the medication, so those who might need it -- particularly in an emergency situation -- can obtain it. In 2013, President Obama passed the School Access to Emergency Epinephrine Act, which encourages states to enact policies to expand access in schools. Since then, several states have been pushing laws to provide epinephrine to schools, businesses, sporting events and more. First responders have also been given the ability to administer it in the case of an emergency in some places, but largely on a voluntary basis. To get this done, we need epinephrine providers to apply for reclassification of the drug with the FDA. Over-the-counter access comes with its own concerns, so that’s why “behind-the-counter” classification makes sense here. It would give people the chance to purchase an Epi-Pen without a prescription, so they have it handy in the event of an unpredicted emergency like in Dillon’s situation. I’m willing to spend the rest of my life fighting so that no other parent ever has to feel the way my husband and I feel with Dillon gone. We need to raise our voices together and ask the FDA to change its classification of epinephrine so that it is more readily accessible. If you'd like to learn more about Dillon or have any questions regarding this petition, please visit our website, http://epifordilly.com. Thank you for your support!
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
U.S. Food and Drug Administration: Allow gay/bisexual men to donate blood.
Why I started this petition: As a gay man, I do not fit the stereotype of the promiscuous guy obsessed with sex. As a gay man, I am faced with a decision every day of my life to do what feels naturally in my relationship or still keep myself eligible to donate blood. Even though in 2003, the Supreme Court of the United States eliminated the sodomy laws in Lawrance v. Texas, the policy set out by the U.S. F.D.A. still criminalizes an act of love between two consenting adults because of the old fear that gay men are infected with HIV/AIDS. I do not want to have to continue to choose between being able to donate blood over love. Please visit our website to learn more about the project, data, statistics, and our efforts to change the policy at http://www.weallrequal.com. In short ... According to the U.S. Food and Drug Administration (source: A): "Men who have had sex with other men, at any time since 1977 (the beginning of the AIDS epidemic in the United States) are currently deferred as blood donors." Their main arguments are: 1) "Blood donor testing using current advanced technologies has greatly reduced the risk of HIV transmission but cannot yet detect all infected donors or prevent all transmission by transfusions.” 2) "Detection of HIV infection is particularly challenging when very low levels of virus are present in the blood for example during the so-called "window period". The "window period" is the time between being infected with HIV and the ability of an HIV test to detect HIV in an infected person." However: 1) Heterosexuals with multiple partners are allowed to donate blood despite their increased risk for transmitting HIV and hepatitis. 2) The United Kingdom, which recently lifted its lifetime ban in September 2011, instead, allows gay men to donate blood provided that they have not had sex with another man for at least one year (source: B). This is four times longer the amount of time necessary for HIV to reach detectable levels after infection (source: C). The current ban affects all of us, not only gay men. It extends to those who have slept with a bisexual/gay man who has had sex with men, whether they are male or female. This ban has affected sperm donation policies among gay/bisexual men too, and even to organ donations policies. Solution: If the all-out ban on homosexuals/Bisexuals donating blood is reduced to only those who have had a promiscuous sexual contact with another man in the past year, the increased number of potential donors would increase and help the blood pool grow while still keeping the blood supply safe. This petition would allow committed long-term monogamous men to donate blood. Thus the new pre-screening question should be: “Male donors: Have you had unprotected sexual contact with a new male partner in the past 12 months? (Females: check "I am female.")” Please sign this petition to urge the FDA to revise their outdated policies, by remove this excessive and unnecessary ban that prevents homosexuals/bisexuals from donating blood. References: A) U.S. FDA, cited 2012: Questions about Blood & Blood Donations from Men Who Have Sex with Other Men Questions and Answers. [Available online at http://www.fda.gov/] B) BBC News, cited 2012: Gay Man Donor Ban to be Lifted. [Avablable online at http://www.bbc.co.uk/] C) Avert, cited 2012: HIV Testing. [Available online at http://www.avert.org/testing.htm]
FDA: Tell Fluoride Supplement Manufacturers & Pharmacies to Stop Selling Unapproved Drugs
On January 13, 2016, the FDA issued a Warning Letter to a pharmaceutical company (Kirkman Industries, Inc.), ordering the company to "discontinue marketing all of the unapproved prescription drugs manufactured at [the] facility immediately.” The unapproved prescription drugs that FDA identified were fluoride "supplements." Fluoride supplements are sodium fluoride containing drops, tablets, and lozenges that are sold for the purpose of preventing tooth decay. FDA's Warning Letter makes clear that marketing fluoride supplements as cavity preventatives violates federal law because the FDA has never approved fluoride supplements as safe and effective for this purpose. The FDA’s Warning Letter is a commendable step in the right direction, but FDA should not limit its enforcement action against fluoride supplements to Kirkman, as there are other, larger companies that are currently making and selling the very same fluoride supplements, and these drugs are being sold throughout the country by the nation’s four largest pharmacies: Walgreens, CVS, Rite Aid, and Walmart. Each and every one of the issues that FDA identified with Kirkman’s fluoride supplements applies with equal force to the fluoride supplements being manufactured and sold by these companies. The unlawful actions of fluoride supplement manufacturers and sellers are unnecessarily placing millions of children in harm’s way. An overwhelming body of evidence shows that fluoride works topically, not by ingestion, so there is no need for children to be swallowing *any* fluoride, whether in drops, tablets, or any other form. The prestigious Cochrane Collaboration has concluded that fluoride supplements are ineffective and unnecessary. Fluoride supplements are not just ineffective, they're dangerous. Fluoride is now classified as a developmental neurotoxin and endocrine disrupting substance. Ingesting fluoride during early childhood poses serious potential risks to brain development and thyroid health, as well as other harm, including dental fluorosis, bone fragility, and osteosarcoma. The problem today is not under-exposure to fluoride, but over-exposure. The most recent national survey by the U.S. Centers for Disease Control shows that up to 64% of adolescents now have dental fluorosis, with up to 29% of children having advanced forms of this condition. Fluorosis is a visible mineralization defect of tooth enamel caused by excessive fluoride intake, which can be disfiguring when present on a child’s front teeth. Rather than continuing to increase children’s intake of fluoride, the urgent need now is to find ways to reduce it. Removing unapproved, ineffective, and dangerous fluoride supplements from the market is one important and obvious way to do so. The Fluoride Action Network (FAN) & International Academy of Oral Medicine & Toxicology (IAOMT) have filed a petition with the FDA calling on the Agency to take action against all companies selling these drugs. Please sign this letter to tell FDA that you agree! All signatures collected will be uploaded to the FDA website before the comment deadline on the Petition.