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?
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.
#CutFDARedTape: Abolish Cruel, Wasteful FDA Dog Testing Requirements!
Outdated U.S. Food and Drug Administration (FDA) regulations are slowing the search for a cure to COVID-19 and other illnesses by forcing drug makers to conduct unscientific and extremely cruel drug safety tests on puppies.As a pathologist with expertise diagnosing human disease, I can say with certainty that dosing puppies with drugs designed for humans is not just inhumane, but wasteful and unnecessary. It also will not make people safer—in fact, the FDA's dog testing mandate harms human health and wastes precious resources.I hope you will join me and White Coat Waste Project to help #CutFDARedTape, and abolish the FDA's wasteful and cruel dog testing mandate!The government’s own data shows that over 90 percent of drugs that are effective in animal testing, fail in humans—because they are ineffective, or because they show dangerous side effects not predicted by the animal trials.Yet, the FDA continues to require that companies waste millions of dollars to force beagle puppies to swallow or breathe doses of experimental drugs daily for up to a year, after which they’re killed. At least 20,000 dogs per year are experimented on and killed to comply with U.S. government regulations like these, and that number may be even higher.Even when companies want to use superior alternatives to dog testing, which FDA rules allow, the agency often refuses to permit it and punishes them for challenging the requirement.Please sign my petition and join me and White Coat Waste Project in urging the FDA to spare dogs, stop waste, and save lives by cutting FDA red tape!Sincerely,Dr. Tiffani Milless
FDA: Please expedite NUROWN Treatment for ALS Patients
My husband David is suffering from ALS - or Motor Neuron Disease. There is no cure and currently no effective treatment to slow down the progression of this horrific disease which destroys the body's neurons leaving the patient trapped in a lifeless body. We have a young family of three daughters and we cannot lose Dave without a fight! There is a treatment called NurOwn that is at stage 3 of clinical trials - it is the first ALS treatment that is showing decent results. Some people who have been in the studies have reported impressive improvements in their health and muscle function. With this stem-cell treatment, fathers, husbands and sons like Dave have a real shot at living longer with their families. We call on President Donald Trump and the FDA to make this treatment available to everyone by expediting the clinical trials process. Stage 3 means it has passed tests that make it safe for humans - we are wasting valuable time having to wait for the stage 3 trials to be completed. Please sign our petition - if every ALS sufferer had this chance so many lives could be extended to make memories with their families. Thank you. Please follow our story on Facebook at Live Fast, Take Chances. Also, we have set-up a Go Fund Me to help our family with the enormous, crippling costs that ALS brings. We would appreciate any help no matter how small! Thank you all so much! https://www.gofundme.com/f/live-fast-take-chances-for-david-keeble
We the people of the World want to stop the emanations affecting the climate
We can not allow the continuos of gases emanations affecting the global temperature. If we the people of the world took care of the fires of the Amazon, we also want to push the Mayor Nations of the world to stop this now! But Now!
Novartis | Reduce $2.1M price of Life-Saving Drug, Zolgensma, for Spinal Muscular Atrophy!
Everyone should stand up for affordable access to lifesaving drugs!!! In May 2019, the Food and Drug Administration (F.D.A.) approved a gene therapy, Zolgensma, for Spinal Muscular Atrophy (SMA). SMA is a rare genetic disease that progresses rapidly in babies. If left untreated, even for days, SMA causes a permanent damage to babies. Zolgensma was developed by AveXis, Inc. and is sold by the Swiss drugmaker, Novartis. The drug is intended for babies under the age of two. Priced at $2.1 million per patient, Zolgensma is one of the most expensive drugs on the market. But given that the F.D.A. provided an accelerated approval process through Fast Track, Breakthrough Therapy, and Priority Review designations that saved hundreds of millions for Novartis, the drug price should have reflected that reality. Type 1, also known as the Werdnig-Hoffman disease, is the most common and aggressive form of SMA, affecting babies’ nerves and muscles. Babies with Type 1 do not produce enough protein because they are missing the SMN1 gene. They gradually die suffering grievously by being deprived of basic life functions like crawling, swallowing, and eventually breathing. Many newborns die within months, most other children do not live past age two. Therefore, the sooner the drug is administered, the better the results to maximize the outcomes of receiving the drug as Zolgensma does not reverse any damage already done. Zolgensma is simply out of reach for many suffering babies. Delayed accurate diagnosis and treatment leave parents with little time to find ample financial funds. While insurance companies may take the financial burden off of parents in the U.S., at the end, we all pay this astronomical price for this drug. On the other hand, if parents are forced to raise money through crowdfunding, out of the lack of available options, the treatment for babies is largely delayed. Even worse, some babies are left entirely out of the treatment! In May of 2021, Zolgensma entered the third year of being sold at the $2.1 million price tag, unlike any other sophisticated drugs for rare diseases. Novartis AG, reduce the universal drug price of $2.1 million for Zolgensma by tying the safety and effectiveness of the drug to its pricing. Consider all generous incentives received by the F.D.A., not its fast-producing profit. Not only will that shorten the time of raising sufficient financial funds and assess the price of Zolgensma properly but will also save more babies! According to ICER, "Zolgensma’s price for Type I patients would need to be between $710,000-$1.5 million per treatment." Once the price is reasonably reassessed, more countries will cover the treatment of Zolgensma ending ultimately the pain of afflicted families. Expand Global Managed Access Program (MAP) beyond 100 free-of-charge doses per year to make Zolgensma available to eligible patients in countries where there is lack of such treatment. Include more countries in the program. Every month, there are 30 babies born with SMA in the U.S. Extrapolate that across the globe! SMA affects babies equally despite gender and race worldwide. There is a huge need for expanding the program especially in regions where treatment is out of reach. SMA - BLOG (Part I) SMA - BLOG (Part II) PLEASE SIGN & SHARE.
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!
Cancer nearly killed me because I was denied a mammogram!! Change the minimum age to 18+
Cancer can occur at any age. Early detection and prevention is the key to beating it. Mammograms should be available at any age, not just for women who are 40 years or older. Under current legislation, thousands of women could die because they are being denied this life saving medical Test. I know this because I personally was denied a mammogram four different times, WITH a family history of breast cancer and a medically declared breast lump, at the age of 32. The result of this allowed my cancer to spread and become more aggressive and require more treatment. It almost killed me and I am still struggling with fighting it. Younger women with breast cancer experience unique challenges. For women under 40, breast cancer is often diagnosed in its later stages, when it tends to be more aggressive. This means the survival rate is lower and the recurrence rate is higher. This is not ok. As of January 2019, there are more than 3.1 million women with a history of breast cancer in the U.S. This includes women currently being treated and women who have finished treatment. Early prevention should be a choice! We are considered adults at the age of 18. We are allowed to vote, and make adult decisions. If we feel something is wrong with our own bodies, we should NOT BE DENIED the right to be heard and checked. Please join me in spreading this petition and getting it heard!!! If I can make one good thing happen out of this horrible hand I’ve been dealt, it would be to spread awareness and help save others’ lives!!
Get the FDA to act on BCG Shortage for Bladder Cancer
There is a global shortage of BCG (Bacille Calmette Guerin), an extremely effective immunotherapy drug used as treatment for bladder cancer. More than 80,000 people in the United States were diagnosed with bladder cancer in 2017. Currently, Merck is the only manufacturer of BCG. Because of increased global demand, and only a single supplier, there are severe shortages in the U.S. and many other countries for 2019 and beyond. To minimize disruption to patient care and address the current imbalance between supply and increased global demand, we must get the FDA to act by working with other firms and drug manufacturers that make the drug and ask if they can ramp up production to fill any gap in the domestic supply of the product.Urge the FDA to identify foreign versions of the product with the same active ingredient manufactured by reputable firms. FDA can then use enforcement discretion for the limited importation of the foreign version until the shortage of the FDA-approved drug is resolved.Implore that Merck increase the production of the BCG for intravesical use, and not let profit get in the way of saving and improving lives of Bladder Cancer patients.Merck must have the foresight and properly plan for this highly effective life saving drug to always be accessible and adequately available to cancer patients.I started this petition because...My energetic and resilient father is battling Cancer for the third time. Very recently, he was diagnosed with Bladder Cancer. At a young 76 years of age, he underwent a transurethral resection of the bladder in February 2019. A treatment regimen was planned to administer a series of six treatments with BCG, a life saving treatment with minimal side effects. Instead my father had chemotherapy treatment because there were no BCG available. The chemotherapy treatment could not be tolerated and had to be discontinued, severely degrading his quality of life. He remains at risk of the Cancer growing back and spreading, and of not recovering at all. The alternatives to BCG treatment are very costly, life threatening surgeries and treatments. Please help my father and thousands of others live long healthy lives; and not suffer and die because they don't have access to BCG to treat and hopefully beat Bladder Cancer.
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/