Federal Drug Administration
Federal Drug Administration
ALS patients can’t afford the wait. Fast track decision on bring drug to the United States
It’s been over 20 years since a new treatment for ALS, a progressive neurodegenerative disease that affects nerve cells in the brain and the spinal cord, has been available in the US. That could all change with Radicava, a drug already available in other countries and that extends the lives of those with ALS. The Food and Drug Administration (FDA) is reviewing the drug and say it should make a decision by summer of 2017 -- that is too long. And even if a decision to bring the drug to market is reached, it could take 6 months to get it to pharmacies. People suffering from ALS need this drug, thousands of patients will not make it that long and need access as soon as possible. This isn’t the case of a drug that has never been available to the public and where higher scrutiny would be understandable. Radicava has been available in Japan and South Korea, and hasn’t shown anything that would indicate it is not safe. Sign our petition telling the FDA to expedite their decision. People with ALS should not have to wait for a proven drug until the end of 2017, or possibly not until 2018. It’s been 20 years since any kind of new treatment for this awful disease -- they’ve waited long enough.
Make Chronic Pain Patients exempt from CDC Guidelines
The CDC guidelines are causing doctors to leave pain management practice all over the US, for fear of DEA malicious prosecution if they exceed an arbitrary and unscientific “one size fits all” policy while trying to treat their patients effectively and as individuals. Patients are being deserted by their doctors, in some cases without assistance in drug withdrawal, after they have used opioids as directed, safely and effectively for years to maintain the quality of their lives. Almost certainly some patients have already died and more will commit suicide as a result. Our government is aware of this problem, but chooses to do nothing. The guidelines are also being embedded in State laws that reinforce restrictions on opioids. Major areas of several US States are now without pain management centers, and remaining specialists are seeing ever-heavier patient loads and higher risk of prosecution. The best predictors for people falling into addiction are their age (teens are particularly vulnerable), and their status as unemployed or poor. Restriction of opioid medications to pain patients won’t solve these problems. If anything, we should anticipate increases in deaths due to street drugs, as desperate people are forced to seek them out against their own wishes, just to maintain a marginal quality of life. The CDC needs to withdraw its unscientific and damaging opioid guidelines. Revisions should acknowledge that at the present state of medical knowledge, opioids are an indispensable part of managing agonizing pain, and trained doctors are the best decision makers on how much is needed to relieve pain in each individual patient. Standards of practice and doctor training are needed. But the present CDC guidelines are a poor basis for such standards. Re-writing should be accomplished by professionals who actually understand chronic pain and its management, and not by addiction specialists who have a financial self-interest in diverting limited government resources away from proven pain treatments. For the longer term, the US National Institutes for Health needs to allocate far more research and resources to the study and treatment of chronic pain. At present, less than 1% of NIH research funds are directed to chronic pain – for one quarter of the US population. The percentage of chronic pain patients who abuse their medication is less than 1%. There are well over 100 million people in the US suffering from some for of chronic pain. The only "epidemic" in this country is heroin and illicit fentanyl coming in from China and Mexico. Addicts are being catered to while the chronic pain community is suffering, turning to illicit drugs or committing suicide. It is time to STOP THE WAR AGAINST PAIN PATIENTS! We have rights too!
A petition to Scott Gottlieb (FDA) to recuse himself from decisions regarding Kratom.
We the people petition FDA Commissioner Scott Gottlieb to recuse himself from any decision making or public statements regarding the plant Kratom. From the first announcement of Dr. Gottlieb’s nomination as Commissioner of the FDA his ability to remain impartial was called into question because of his strong ties to many of the largest pharmaceutical companies, including GlaxoSmithKline PLC and Cephalon. There is now clear evidence that casts reasonable doubt on his ability to remain unbiased on the issue of kratom. It is a matter of public record, near the point of common knowledge within the kratom community, that Dr. Gottlieb has been a member of GlaxoSmithKline’s Product Investment board from January 2010 until present. As a member of the Product Investment board he would no doubt be aware that GlaxoSmithKline once held 2 US patents regarding isolation of the alkaloid mitragynine from Mitragyna Speciosa, the latin botanical name for kratom.  The patent that GlaxoSmithKline owned very clearly praises Mitragyna Speciosa (aka kratom) as “less depressant effect on blood pressure and respiration than codeine with no apparent cardiovascular liabilities. Decreased toxicity is also observed in comparison to codeine.” It also touted the compound as having “minimal side effects”. These findings have been backed by numerous studies conducted by leading pharmaceutical scientists of today including: Dr. Jack Henningfield, Vice President of Research, Health Policy and Abuse Liability, at PinneyAssociates, and Adjunct Professor of Behavioral Biology, The Johns Hopkins University School of Medicine. Dr. Henningfield is one of the world’s leading experts on addiction and safety.  University of Florida Medicinal Chemistry Professor Christopher McCurdy.   Scott Hemby, a professor of pharmaceutical science at North Carolina’s High Point University.  Marc T. Swogger, Ph.D. Department of Psychiatry University of Rochester Medical Center Rochester, New York. Zach Walsh, Ph.D. Department of Psychology University of British Columbia Kelowna, BC Canada. Oliver Grundmann, Ph.D. College of Pharmacy Department of Medicinal Chemistry University of Florida Gainesville, Florida. Albert Garcia-Romeu, Ph.D. Psychiatry and Behavioral Sciences Johns Hopkins University School of Medicine Baltimore, Maryland. Robert B. Raffa, Ph.D. Professor of Pharmacology Temple University School of Pharmacy Research Professor Temple University School of Medicine Philadelphia, Pennsylvania. Roland R. Griffiths, Ph.D. Professor of Behavioral Biology Professor of Neuroscience Johns Hopkins University Baltimore, Maryland. Paula Brown, Ph.D. Director of Applied Research, Natural Health & Food Products British Columbia Institute of Technology Vancouver, British Columbia. Both Professor Christopher McCurdy and Professor Hemby were featured on PBS News Hour discussing their findings on kratom and it’s potential benefits in the opioid crisis.  In the past months Commissioner Gottlieb has taken aim at kratom in an effort to pressure the DEA to take action against it despite the pleas of over 100,000 members of an astoundingly diverse community of veterans and civilians alike for safe access to this plant. In both statements he has completely contradicted both the patent once held by GlaxoSmithKline and the findings of the leading scientists in this field of study. His statement in November 2017 faced backlash not only from the scientific community but from both Houses of Congress.  In their letter addressed to Dr. Gottlieb, Congress not only addressed and debunked the 2 main issues of his statement but they requested “that the FDA reconsider its stance and take a closer look at the facts and recent science regarding this plant.”  Based on Commissioner Gottlieb’s statement released February 6, 2018, it would seem that he has declined to do as Congress requested. Rather than continued scientific study, his statement heavily references an FDA computer simulated model. His bias is readily apparent in his backing of a computer simulation that gives him the results he wants rather than the scientists who have dedicated years of research to kratom. Their research completely contradicts the computer model. No one put it better than Dr. Hamby “They make a lot of hay of using a computer model, but it's really nice to validate the findings with actual science.”  Unable to validate his desired results with actual science, Commissioner Gottlieb is choosing to trust and advocate a computer simulation. Of course, the obvious flaw in a computer simulation is the results are only as good the information programmed into them. If that information is biased, the results will also be biased. It can logically be concluded that based on how contradictory the computer model is to the actual science that has been conducted that it is probable that the data the model is based on is biased. All the scientists listed above have spoke out against Commissioner Gottlieb's unfounded attacks on Kratom.  On February 8, 2018, just days after the FDA's statement 9 of the above scientists wrote to the White House directly to address this matter. Not only do they refute the claims of the FDA, they refer to kratom twice as a "lifeline away from ...opioids". They spoke out strongly opposed to any action from the DEA and FDA. As creditable scientists, they offered a number of studies published studies to reinforce their belief. [10 a - e] Even if, by some small possibility the computer model is in fact accurate, since when does the FDA, or any branch of government, rely on computer simulations to drive policy? Commissioner Gottlieb has said that he is committed to ending the opioid crisis which is commendable, especially since in 2008 he seemed to take a favorable stance toward synthetic opioids when he gave expert testimony on behalf of Cephelon, one of the largest fentanyl manufactures in the country. This fact was one of the key questions that congress had for Dr. Gottlieb when he was first nominated as Commissioner of the FDA.  Incidentally, in the case that Dr. Gottlieb was paid to defend their actions, Cephelon pled guilty to criminal charges that they promoted their fentanyl products for off-label uses other than what the FDA approved and paid a $425 million dollar fine for their actions. This case demonstrates that at least at one point in history, Commissioner Gottlieb not only favored synthetic and harmful opioids, but his willingness to put his name and reputation on the line for financial gain. In August 2016 the DEA announced it’s intent to classify kratom as a schedule 1 drug, however due to scientific research, public outcry and calls by Congress to overrule the decision they withdrew their intent in October 2016. They decided to allow the scientific community the space and time necessary to continue studying kratom and it’s possible benefits to society.  As Professor McCurdy states "We must be able to do the research, if (kratom) goes Schedule I, this will make it nearly impossible to do so.” Commissioner Gottlieb must follow the example set by the DEA and allow further actual scientific study to be conducted on kratom without constant pressure, threat of actions or attempts to discredit findings from the head of a government organization. Given Commissioner Gottlieb’s past financial ties to big pharmaceutical companies like GlaxoSmithKline and Cephelon, his willingness to accept computer models over actual science and his being a member of the product investment board of the only pharmaceutical company that has held patents on kratom, it is clear he can’t approach this topic with true impartiality and he must recuse himself from any further decisions involving kratom.  US Patent 3,256,149 (Expired) http://bit.ly/2nORi9O, US Patent 3,324,111 http://bit.ly/2EsDsnW  http://220.127.116.11/HL-AKA-Eight_Factor_and_Recommendations_by_PinneyAssoc.pdf  http://pharmacy.ufl.edu/faculty/christopher-mccurdy/  https://www.youtube.com/watch?time_continue=1&v=ieItgEbKpsU  http://www.highpoint.edu/blog/2017/02/faculty-recognized-for-research-and-innovation/  https://www.pbs.org/newshour/show/kratom-help-treat-opioid-addiction  https://polis.house.gov/uploadedfiles/kratom_fda_health_advisory_letter.pdf  https://polis.house.gov/uploadedfiles/kratom_fda_health_advisory_letter.pdf  https://www.cnn.com/2018/02/06/health/fda-kratom-opioid-bn/index.html  http://bit.ly/2nUP0pF [10 a] http://bit.ly/2nMRszm [10 b] http://bit.ly/2BOOG5i [10 c] http://bit.ly/2nTRogs [10 d] http://bit.ly/2Ee9YuR [10 e] http://bit.ly/2EaFv0o  http://bit.ly/2E88Jgt  https://www.uspharmacist.com/article/the-dea-changes-its-mind-on-kratom #keepkratomlegal #plantsnotpills #notanotherdrug
Mattie's Policy- Medicine For Mattie, for ALL.
Attention: I'm doing this for my friend and the future of our health care. Jaclyn White. We have a victory for Mattie. Now, can we please keep this going to make changes for all who are in need of medicine. Let's make a change in policy, by signing this petition. Don't allow someone behind a desk make decisions on your life!! Doctors need to have the final say and what is best for their patience. Please share.... Something has to give. No more taking whatever is handed to us. You PAY for insurance and yet we allow them to dictate what they will cover. Stop this kind of abuse of power from Insurance and pharmaceutical companies! Mattie's Policy- for ALL with and without insurance, that need treatment for their life. Dear Anyone Who Can Help, I am writing you on behalf of my 9 year old son Matthew. We call him Mattie, and we live in Newnan, GA. He is a smart, funny, stubborn, bright young man who loves playing video games, feeding and caring for his chickens, and helping his family. Mattie had a 2nd surgery to remove a dangerous spinal cord tumor from his spine at C3-C4 that was compressing his spinal cord. Unfortunately, Mattie suffered a spinal injury during surgery. He also had issues with his heart rate and blood pressure after surgery that put him in the intensive care unit at Children’s Healthcare of Atlanta at Scottish Rite. They stopped the surgery and were unable to remove all of the tumor. At that point keeping Mattie alive took priority over removing all of the tumor. Since then, he has had to undergo intensive rehabilitation at Children's Healthcare of Atlanta. He was unable to walk, move his left arm, or feed himself after surgery. Thanks to the Rehabilitation program at Children's Healthcare of Atlanta, he is able to walk short distances and is gaining back his endurance. However, his arm is still paralyzed at the shoulder. As proud as we are of our son, his battle is unfortunately not over. His team of experienced doctors want him to try an oral chemotherapy called Mekinist in order to attempt to shrink the tumor. However, the FDA has only approved it for melanoma. They want to do something called using this medication off label. There are no other chemotherapies available on the market that will help him. Because of the FDA labeling, our insurances will not approve the medication. His doctors are doing all they can to help him get the medication. Matthew has UnitedHealthcare as his primary insurance, CVS Pharmacy (Caremark) as his prescription coverage, and Georgia Katie Beckett Deeming Waiver Medicaid (Georgia Department of Community Health) as secondary insurance. The drug manufacture Novartis, is denying him patient assistance because he has insurance. The medication costs are 1/10 of the cost of what it will incur for the costs of his surgeries and rehabilitation. It's more cost effective and logical for Mattie to try this medication. If it shrinks these tumors, he will be able to grow up and become a productive, tax paying adult. If these tumors keep growing, he will become a ventilator dependent quadriplegic. The cost to the state of GA and federal government for his long term care will be astronomical. It's in everyone's economic best interest to try to help Mattie get access to this life saving and tumor shrinking medication. Also, the cold facts are, that if he has more surgeries, he is likely to suffer more spinal injuries and quite possibly not survive. I am begging you as his mom to help. If you can help influence anyone to approve this medication for my baby, I would be forever grateful. You have the power to help him if you so choose. His life, future, ability to walk and grow up, are literally in your hands. Please help us. You could quite possibly be his only hope. All I want for Christmas is for my baby to get a chance at being able to use this medicine. Respectfully,Katie McKoy
Investigation into AWL Chicago Ridge’s substandard living conditions of the animals
We are requesting a third party investigation of Animal Welfare League In Chicago Ridge , Illinois, which is a non-for profit, private animal shelter. These photographs were FOIA’d from the Illinois Department of Agriculture In 2015. How could these unsanitary, unsafe, deplorable conditions pass the IL Department of Agriculture’s inspections ? Aside from the health risks these already sick animals are exposed to, what about the health and safety of the employees and volunteers? This problem has existed for years and still exists today! As you can see in the photographs of the shelters garage, animals are being kept in their kennels next to pigeon coups. The pigeons are defecating on, in and around these dogs, despite having “cardboard boxes” for crate covers !! These conditions are horrific, unsafe, unhealthy, deplorable, substandard conditions and should not be allowed. We do not want AWL shut down, but want to make it what it should be, a safe and clean place for the animals. This shelter needs to get rid of current management and board members, and bring in people who care about the lives of these animals !!
Stop Making Chronic Pain Patients Suffer
My name is Ashton Smith. I deal with chronic pain every single day of my life. Pain medication helps me live a semi normal life but the war on opioids has done nothing but harm people like me. The DEA has doctors afraid to prescribe anything for people in legitimate pain for fear of the DEA: who threaten their licenses. Everyone keeps asking for harder laws due to the heroin "epidemic" but this epidemic is caused by the harsh 2014 rescheduling of opioids. People in chronic pain are resorting to heroin or suicide because no one is treating their pain. Multiple studies have shown people with chronic pain rarely abuse their medication. We ask the DEA to think of us when you make it harder for us to function. Allow doctors to BE doctors & stop the war on chronic pain patients
Legalization of Marijuana
This petition supports the legalization of marijuana. This document will inform citizens and the government on how the benefits of legalization will prevail the disadvantages. Legalization of marijuana will not only boost our economy but can also affect people’s choices on how to use this drug properly to avoid complications. The legalization of marijuana is a pressing point in question. Fifty-two percent of Americans over eighteen have tried marijuana at some point in their lives. Why has the government not taken advantage of this economic prosperity? Cannabis/Hemp can be the largest cash crop since cotton and legalization can lead to a boost in the economy and create American jobs. Colorado has brought in nearly $73.5 million in selling marijuana and marijuana-related products in just a few years. Creating jobs and increasing cash flow is one of the many reasons why recreational marijuana should be legal. Many accept different views on how marijuana can or cannot be harmful. An estimated 88,000 people (approximately 62,000 men and 26,000 women) die from alcohol-related causes annually, making alcohol the third leading preventable cause of death in the United States. The first is tobacco, and the second is poor diet and physical inactivity. On the other hand, marijuana can cause lung cancer, psychiatric events, serious cerebral and cardiovascular complications. I do not believe the claim that no one has ever deceased from consuming cannabis. The more serious complications of marijuana, however, are rare. Who is most likely to experience these serious complications? According to drugabuse.gov, marijuana’s effects on a person depends on a number of factors, including the person’s previous experience with the drug or other drugs, biology, gender, how the drug is taken, and the drug’s potency (its strength). If marijuana is legalized, the government can control three of these factors: the person’s previous experience with the drug or other drugs, how the drug is taken, and the drug’s potency (its strength). The government can monitor dispensaries by monitoring the potency of products, putting an age limit on who can buy from dispensaries, and lastly what kind of marijuana products they sell. The federal government will benefit from the legalization of marijuana due to increase control over the marijuana business. Not to mention, doctors prescribe marijuana as a medication to patients with cancer, chronic seizures, nausea, Alzheimer's, and HIV/AIDS. The list continues on conditions in which marijuana can be prescribed.If you agree with these reasons on why marijuana should be legalized please sign this petition.
Develop procedures and/or testing to separate addicts from pain sufferers!
As an advocate for chronic and intractable pain awareness and laws (and being a pain sufferer myself), I wrote this petition to appeal to you (President Trump, CDC, FDA and DEA) that we understand the war on drugs and wanting to stop the overdoses, abuse and addiction caused by illegal use of various substances (including opioids) is justified. However, it is causing harm to real chronic and intractable pain sufferers. The harm goes from a low to no quality of life to suicide! We deserve to be treated like human beings and taking away a big part of pain management is inhumane. Many strategies and options exist to treat chronic noncancer pain. Since chronic and intractable pain is not a single entity but may have myriad causes and perpetuating factors, these strategies and options vary from behavioral methods, alternative medicine, rehabilitation approaches and using several different medications, including opioids to help the pain sufferer. We now are looked at as addicts and abusers when in fact many of the pain patients that I have come in contact with throughout the world are just the opposite. They follow their doctor's guidelines perfectly. The biggest question that is asked all the time is "what does it feel like to get high"? Pain patients medications are going to the areas of the body to help their pain and thus no extra medication to get high. Treating pain sufferers is very difficult. Treatment plans made by a team of doctors is the best way. This includes, internal medical doctors, psychologists, occupational therapists. physical therapists, dietitians, alternative medical doctors, holistic medicine and homeopathic medications. I realize this is a lot of specialists, but I feel they at least should be available to the patients. Our bodies are all different (as you know) so using a one size fits all way of treating pain will not work! We have no problem with some all-inclusive pain treatment plan using other methods with the opiate treatment, but just cutting people down to a one size fits all approach to opiates is insane and will cause more suicides with the pain population. You may help the abusers, overdoses, and deaths from those individuals you are trying to help, but you will cause more suicides and deaths from those pain patients who really need their medications. This makes our pain sufferers collateral damage! We are tired of being collateral damage in the "war on drugs"! This war has been going on a long time and you have all had issues separating addicts and abusers from those people who have chronic and intractable and need opiates and other medications to have some semblance of normalcy. This is a violation of our human rights! Please stop the suicides and treat chronic and intractable pain sufferers with treatments that their physician deems appropriate!
Demand affordable prices for pulmonary hypertension medications
Demand affordable prices and better financial aid for Medicare patients who have pulmonary hypertension. Caring voice coalition was providing foundational grant assistance to Medicare patients who cannot afford their pulmonary hypertension medications for the entire 8 years I've been employed working in this disease state. The government has forced them to shut down leaving thousands of patients without financial assistance for their current pulmonary vasodilator medications that help elongate their life expectancy and alleviate some symptoms related to this disease. The government did not give any direction to patients who relied on caring voice Coalition for financial assistance and a lot of them are stopping their medication because they can't afford a 33% coinsurance of over $25,000 a month. With strict laws governing Medicare, recipients are not allowed to use the manufactured copay assistance, coupons or any other offered discount given by the pharmaceutical companies who makes the drugs therefore leaving the patient in a financial bind. Please share this petition and raise awareness. There are other grant organizations that have graciously stepped up but unfortunately the amount they offer is not enough to cover most coverage gaps or the part D "donut hole" as it is referred to. Once Medicare pts get into this coverage gap they are the forced to pay 100% of not only their pulmonary hypertension medications but their other regular medications as well. caring voice Coalition was giving patients $20,000 a year to help offset most of the cost of the out-of-pocket expense for patients on Medicare. And most of these Medicare patients are also on a fixed income which means they are already struggling to survive much less are they able to afford these very expensive meds. Please allow Medicare patients to receive coupons, discounts and manufacturers financial assistance programs.
Make Ibogaine legal for opiate addicts
The heroin epidemic is out of control and we need solutions!!! Here's ours... My daughter was a $400.00 a day heroin/fentanyl user, using heroin for at least 4 years. When we almost lost her I decided to get angry. Angry at the drug that is. I started talking about it and searching for a way to save her. One day I was in a business meeting when her ex-boyfriend walked in and simply asked how she was. After a rather embarrassing cry I had to give an explanation and one of the gentlemen asked if I had heard of Ibogaine. Of course I hadn't so he shared what he knew, he had heard of it on Law &amp; Order of all places! Grasping for any chance to save my daughter I started researching, talking to friends in the medical field and a company that sells Ibogaine. It seemed too good too be true, even with the risks. My daughter had sepsis and was close to death when she was dropped at the doors of the local hospital by her "friends", and without this treatment she would not be here! **I'm going to leave a little of the story out here aka plead the 5th** When my daughter took the Ibogaine we were naturally nervous because ultimately it was a drug, so the plan was to go directly to the ER. Luckily the nurse on duty had experience with the treatment because a doctor she had previously worked with recommended Ibogaine to his patients. The ER doctor on duty had the nurse call poison control and imagine our relief when they said they have seen no serious adverse effects from this treatment and only recommended fluids and monitoring. Now the results have exceeded my every hope for what this treatment would do. Simply amazing! She woke up the next day euphoric. Looking into a mirror she asked me if she looked different, and I could see that she certainly did in her eyes. She was really seeing herself for the first time, that is a feeling I will never forget. My daughter has no withdrawal symptoms, no cravings, stopped taking anxiety and depression medications. She processes information differently than before treatment, sees the world a little brighter and herself clearer. If I'm being honest I wouldn't mind a little of that treatment myself!! Here's the email address for Office of National Drug Control Policy. Have any thoughts on heroin? Pass them along!!! firstname.lastname@example.org