Food and Drug Administration
Food and Drug Administration
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.
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.
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/
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.
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]
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
URGENT! Fukushima Radioactive Fallout Food Safety Petition
THIS IS AN ACTIVE PETITION ~We are in the midst of an ongoing and seemingly incomprehensible radiation crisis at the Fukushima Daiichi nuclear power complex in Japan. Some are saying "this is not Chernobyl" and for that matter it may turn out to be worse. Greenpeace released a report on March 25, 2011 which ranks the radiation leaking from Fukushima to date to be at Level 7 on the International Nuclear Event Scale (INES) which is the the highest level and the same as Chernobyl after that catastrophe. We must remember that this crisis is far from over and will have serious health effects for many innocent people, with young children and the elderly being particularly vulnerable. The National Academies of Science issued a 2006 report on radiation exposure that concluded that even low levels of radiation can cause human health problems, including cancer and heart disease. And 25 years after Chernobyl, the United Kingdom still maintains restrictions on sheep production in parts of Wales because radioactive cesium continues to contaminate grazing lands. Now we are learning that the water pumped in from the ocean to cool the Fukushima reactors is flowing back to sea mixed with deadly plutonium, endangering sea life too. Until workers can find a way to somehow stop, contain and store it, dangerous levels of radioactivity will continue to spread to the ocean and the biosphere. Particulates in the form of radioactiive iodine and other radioisotopes from Fukushima have traveled across the United States as far as Massachusetts. Increased radiation is now being detected in cows milk in Washington, Vermont, and other states. While we continue to send our prayers and support to the people of Japan, it is clearly time to understand that this is a global crisis which will affect many nations, including the United States. Citizens in India, China, France and other countries are being told to carefully handle or not to eat large leafy green vegetables and some dairy products. Here in the US, closer downwind on the jetstream from Japan, we are STILL not receiving honest, accurate and consistent information from our government agencies. The FDA has announced that there is no need to test north Pacific fish for radioactivity, and the EPA announced scaling back monitoring of water and milk to quarterly testing only. First, we need to monitor all food and water imports from Japan, including the estimated annual 5 million gallons of bottled water, soft drinks and other non-alcoholic beverages containing water. Seafood shipments and other food products also are still being imported by the US.and they must be monitored immediately. Next, the Environmental Protection Agency must significantly expand the monitoring of air particulates, rain water, drinking water, and milk and to make the findings readily transparent and immediately available to the public. Last, the United States Department of Agriculture and the Food and Drug Administration should receive adequate funding for expanded food and water inspection both here and overseas and to communicate those findings immediately to the public. Congress must rethink our agricultural policies as well as international trade policies as they effect imports from other countries also trading with Japan.
Eliminate FDA regulation of CLOTH MENSTRUAL PADS (or reduce fee for small businesses)
There is an issue about a product you may not even know exists. The product is the reusable menstrual pad. It is an absorbent pad made from fabrics which can be purchased at any fabric store. It is used in the same manner as the common disposable variety. The difference is that it can be used, washed, then dried for reuse (by the same woman). These are preferred by some women over disposable pads for a variety of reasons. Some of these reasons are decreased lifetime cost, less environmental impact, and sensitivity to commercially available disposable devices. Because these devices are not readily commercially available, many consumers have turned to handmade items sold by small businesses. A quick search of the website Etsy, which hosts sellers of handcrafted items, will show many makers. The trouble is this: the FDA considers menstrual pads (even cloth ones) to be a medical device. Therefore, the FDA forces makers, including those that are small, home based businesses, to be "FDA compliant". For 2018, this certification of compliance costs the business owner $4,624 per year. This regulation does not add any additional safety to these products, which are essentially cloth to attach to ones underpants. There is no "sliding scale" or reduction in cost based on sales. The fee is the same for huge multinational companies as it is for a person making them in a home office. As you can imagine, the fee alone is enough to be a stumbling block for small start-ups. A home-based business would have to sell hundreds of items just to break even on the fee every year. This regulation is stifling business start-ups without adding consumer protection and forcing established home businesses to close when the FDA comes calling for payment. We ask for your assistance in eliminating the FDA regulation for reusable cloth pads or modifying the fee structure to ensure affordability for small business owners.