Petition to HHS Secretary, Assistant Secretary for Health, Dr. Francis Collins, Dr. Elizabeth Unger, CFSAC , Dr. Walter Koroshetz, Vicky Whittemore
#PwME4ICC Demand US Health Agencies Recognize Myalgic Encephalomyelitis as Defined by ICC
We are international medical practitioners and researchers in the field of myalgic encephalomyelitis (ME), ME advocates, patients and their supporters. We are located in the US and in other countries that are affected by US health policy. We call on the US government health agencies to accurately name, define, fund and represent the distinct biomedical disease ME which has been recognized by the World Health Organization (WHO) since 1969 as a neurological disease with the ICD code G93.3 and has been well-defined by the 2011 International Consensus Criteria (ICC). Since October 2015, the US ICD-10-CM classifies ME with the same neurological code, G93.3, as the WHO ICD. We demand the US Department of Health and Human Services (HHS) and all its agencies: Adopt ICC for diagnostic purposes Adopt ICC for research purposes Use ICC on all HHS and all HHS agency websites and all educational materials created by or for HHS and its agencies Educate medical practitioners to use the IC Primer for diagnosis Disseminate the IC primer to educate medical practitioners on testing and treatment Insist that ME researchers use ICC for their research funded by HHS or HHS agencies The Problem: ME has appeared in 50+ outbreaks worldwide and was first named and defined by Dr. A. Melvin Ramsay after a massive outbreak in 1955 in the Royal Free Hospital in London. The disease also appears in the sporadic form and is neurological in nature with immune dysfunction, muscle weakness (including paralysis) and pain as well as affecting multiple body systems. It renders most afflicted unable to work – many become house or bed bound. Severely affected patients are left isolated, unable to tolerate human interaction and often require 24/7 care for basic needs. Currently, there is no FDA approved treatment or cure. In an attempt to mystify and marginalize this severely debilitating disease, government health agencies have misrepresented ME as part of an ill-defined chronic fatigue syndrome (CFS) (Reeves’, Fukuda, Oxford). The latest attempt at obfuscation by the US Department of Health and Human Services (HHS) has been sponsoring and adopting the recommendations by the Institute of Medicine (IOM) (now called the National Academy of Medicine) to use the name Systemic Exertion Intolerance Disease (SEID) and the IOM/SEID criteria. The IOM/SEID definition does not require any neurological or immune dysfunction symptoms and because of its lack of specificity will include many who do not suffer from ME. Research by Dr. Leonard Jason’s group at DePaul University, Frank Twisk, and Asprusten et al. has shown that the IOM/SEID criteria do not define the distinct neuroimmune disease ME as described in the medical literature, classified by the WHO and defined by the ICC. Research affirms that unlike the ICC, the four required subjective symptoms of the IOM criteria are commonly found in many chronic diseases and are not unique to any identifiable disease. In addition, the IOM/SEID criteria lack exclusions for conditions with similar symptoms that are typically found in disease definitions. As a result, the IOM/SEID criteria select a broad, diverse group of people without a common underlying pathology. Research by the DePaul group has found that the IOM criteria increase the prevalence of Fukuda CFS almost three times from 0.42% to 1.2% – or about 4 million people in the US alone. Only a small fraction of that group will be people with ME – an estimated 10 to 20 percent. Many in that broad group will be misdiagnosed with IOM/SEID while they actually suffer from different conditions with some similar symptoms. The confusion caused by the co-mingling of ME and non-ME patients will result in harm to people with ME (#PwME) through the recommendation of inappropriate treatment – as well as to all of those who don’t have ME but are misdiagnosed. Moreover, the use of the IOM/SEID criteria in research (which is already happening) will impede meaningful scientific progress by selecting patients for ME research who do not have the disease ME. We, therefore, reject the IOM recommendations and object to their implementation; SEID does not accurately name, and the IOM/SEID criteria do not explicitly define the distinct disease ME. We further object to the reference by HHS and its agencies in their educational material or otherwise, to the IOM/SEID criteria concerning ME. The government’s malfeasance has already caused too much suffering and premature deaths in over three decades. We will not stand by in silence while more of this whitewashing and harm take place. The time to act is now! We demand HHS adopt myalgic encephalomyelitis as classified by WHO and defined by the ICC for diagnostic and research purposes and all education materials created by or for HHS and its agencies now! References: IOM- Report Guide for Physicians ME-ICC diagnostic and research criteria Note: This includes atypical ME which requires fewer symptoms. IC Primer for Medical Practitioners Chart comparing IOM/SEID and ICC criteria ICC Questionnaire “What is it? Do I fit the Criteria?” Jason et al. June 2015 "Unintended Consequences of not Specifying Exclusionary Illnesses for Systemic Exertion Intolerance Disease." Jason et al. July 2015 "Reﬂections on the Institute of Medicine’s systemic exertion intolerance disease.” Jason L.A. September 2015 “Patients battle for justice.” Frank N.M.Twisk April 2015 “A critical analysis of the proposal of the Institute of Medicine to replace Myalgic Encephalomyelitis and Chronic Fatigue Syndrome by a new diagnostic entity called Systemic Exertion Intolerance Disease.” Frank N.M. Twisk February 2016 “Replacing Myalgic Encephalomyelitis and Chronic Fatigue Syndrome with Systemic Exercise Intolerance Disease Is Not the Way forward.” Asprusten et al. March 2018 “Systemic exertion intolerance disease diagnostic criteria applied on an adolescent chronic fatigue syndrome cohort: evaluation of subgroup differences and prognostic utility.”
Petition to Ralph S. Northam, Virginia State House, Virginia State Senate
Negligent at Haysi Regional Jail
My mother Sondrea Sony Lee-sims, was incarcerated due to not having all her fines paid off. She turnt herself in Wednesday, November 27, 2019 THE DAY BEFORE THANKSGIVING!! passed away on Monday, January 4th 2021. She was a inmate at Haysi Regional Jail Facility until they realized her symptoms were much more serious than they thought. They sent her to Johnston Memorial Hospital in Abingdon and had subsequently released her from their custody after realizing her illness was serious. She had been telling the staff, the doctors, nurses, and guards she was not feeling well and just how hard it was for her to breathe. Most of the responses were "your symptoms aren't that serious". My mother and her cellmate had writing letters to seek help from lawyers and anyone who would listen. My mother already suffered from Sarcoidosis and wasn’t receiving the proper testing and medical attention that she deserved, or proper steps to quarantine and prevent the spread of COVID 19 to others. I want my mothers story out there!! These facilities are playing with the lives that hang in their hands and be they treat them horrible.
Petition to U.S. Senate, Dan Brown, Kathy J. Byron, Lee Ware, Mike Cunningham, Timothy Hugo, Bill Eigel, Jason Holsman, Daniel Marshall, III, Jacob W Hummel, Robert B. Bell, Israel D. O'Quinn, Jamilah Nasheed, Bob Onder, Ron Richard, David E. Yancey, John Joseph Rizzo, Caleb Rowden, Margaret B. Ransone, Dave Schatz, Scott Sifton, Wayne Wallingford, Michael J. Webert, Paul Wieland, Tony O. Wilt, Christopher T. Head, Jeion A. Ward, Mark L. Keam, Eileen Filler-Corn, Kaye Kory, Joseph C. Lindsey, Lamont Bagby, David J. Toscano, Steve E. Heretick, Michael P. Mullin, Jeffrey M. Bourne, President of the United States, Maria Chappelle-Nadal, U.S. House of Representatives
Stop Forcing Mail-Order Pharmacy as the Only Option of Coverage
Patients' lives depend on choice. **Since starting the petition, I have realized that there are many issues other than temperatures with forced mail-order pharmacy. Mail-order pharmacy is very loosely regulated. There are life-threatening delays, lack of face-to-face relationships with pharmacists for people with chronic conditions, and rapid closures of our independent pharmacies; although, a recent study showed people prefer independent pharmacy (2018, Gill). *************Our Story************* Our son received a life-saving liver transplant at the age of 2 from a 3-year-old little girl. His life depends on the potency and effectiveness of chemotherapy or immune suppression medications every 12 hours to prevent his body's immune system from fighting off his transplanted liver. In the past mail-order pharmacy delivered his liquid oral medications in nothing but a plastic envelope on a 102-degree day on a hot enclosed non-temperature controlled UPS truck. Shortly after, he went into liver rejection which could have resulted in complete liver failure or death. I speculated that the medication could have been too weak after the delivery of medications in high heat. I vowed to never again risk his life with mail-order pharmacy. Recently, we were mandated or forced to only use mail-order pharmacy in order to receive coverage for his life-saving medications. The package arrived in only a bag on a hot day without an ice pack. I now know that the hot non-temperature controlled enclosed delivery truck and mailboxes can reach temperatures up to 120-170 degrees. His labs elevated again afterward. My son wants to know, "Why would they do that?" I contacted the manufacturer, who performs the testing, who informed me that both of my son's medications should be discarded and considered less potent once stored above 86 degrees as higher temperatures and freezing could both result in lower potency. I contacted the mail-order pharmacy who refused to replace or take back the medication. They said the law & USP Pharmacopoeia allows them to ship up to 104 degrees, although the manufacturer states it is not proven safe at these temperatures. However, I have received communication from USP Pharmacopoeia who writes guidelines for storage, and they also said that the mail order pharmacy should follow the manufacturer's guidelines of 59-86 degrees for storage. Again, the trucks reach up to 170 degrees which is much hotter than 104. I contacted the FDA, who states that the mail order pharmacy should be using the manufacturer's guidelines that have been proven safe. Since the mail-order pharmacies are regulated loosely by the State Board of Pharmacy, not the FDA, there was nothing that the FDA could do. I made over 30 calls to the insurance company begging for them to please let us pick my son's medications up at the local pharmacy at which they are filled. My son's physician wrote an appeal and his transplant team has stated that they have tried to voice their concerns about this issue with their pediatric/child patients and no one is listening! The insurance company still denied the doctor's appeal for us to pick up my son's medications in the safest way. It was not until the Media became evolved that the insurance company budged. I felt helpless and have united with many other pharmacists, physicians, patients, mothers and fathers, and caregivers who feel the same way. Helpless. Mail-order of prescription drugs should be a choice, not the only option of coverage. Mail-order pharmacies may appear to save money, but when my son ended up in the hospital after taking medications that could have been compromised by having lower potency, the cost of the rejection was thousands of dollars. If his liver would have fully failed, the cost of his liver transplant for just 5 days (he was in the hospital for 5 weeks) was over $1,000,000. The lax regulation and oversight may save money on prescription drug plans but may come at an increased cost to the health plan itself. Also, keep in mind the endless waste of medications that automatically are sent regardless of whether or not patients need them. Also, people with chronic, complex conditions, should always have the option of face to face interaction with a pharmacist who knows their complex needs and medical history. The pharmacist and patient relationships are crucial to the successful outcome of the patient's overall health. Taking this away is harmful to patients and be more costly to our already stressed healthcare system. Only allowing mail-order pharmacy for coverage is unethical and irresponsible. I share stories on my social media sites every day of patients who are suffering from a lack of choice. We need your help to make mandatory mail-order an option, not a mandate. YOUR URGENT SUPPORT WILL SAVE LIVES! THANK YOU!! WE APPRECIATE ALL OF THE SUPPORTERS, CAREGIVERS, & PATIENTS. Thank you, Loretta Boesing, Founder of Unite for Safe Medications You may make a tax-deductible contribution to support our advocacy here Email: firstname.lastname@example.org Facebook Page: Issues with Mail Order Pharmacy @justamomwholovesherson Twitter: @BoesingLoretta The greatest way that you can help is by sharing this petition & gathering 2-3 people in your community who are having issues and speak to your legislatures. Reference: Gill, Lisa L. “Consumers Still Prefer Independent Pharmacies, CR's Ratings Show.” Product Reviews and Ratings - Consumer Reports, 7 Dec. 2018, www.consumerreports.org/pharmacies/consumers-still-prefer-independent-pharmacies-consumer-reports-ratings-show/
Petition to Centers for Disease Control and Prevention
Petition CDC to consider Long COVID as a chronic illness
The COVID-19 pandemic has impacted the world in ways that would have been inconceivable a year ago. Hundreds of thousands of people have lost their jobs, their loved ones, and/or their lives. In fact, I was compelled to join this project because I have lost loved ones to COVID-19, and it was disillusioning to observe the media, the government, and many people in the U.S. politicize a public health crisis. Additionally, one of the most terrifying aspects of this pandemic is that we have very limited information about the long term effects of COVID-19, and there are hundreds of thousands of people dealing with long COVID. Almost 20 million people have contracted COVID-19 in the United States, and it's estimated that 10%-20% of them suffer from Long COVID. That's at least 2 million people. One of the issues is that many physicians can be quick to dismiss these COVID Long Haulers because the COVID tests come back negative and researchers don't yet fully understand the implications of Long COVID. I am petitioning the CDC to consider Long COVID as a chronic illness. Currently, the CDC mentions that COVID can cause prolonged symptoms, but that is not enough. Long COVID should be treated as a chronic illness because it is the first step to start discovering treatments for victims of Long COVID. Acknowledging the problem is the first step towards recovery. I'm a student at Stanford University, and I'm working on a project to build a platform for victims of Long COVID to connect with each other and to have access to a reliable and centralized source of information about COVID-19. If you would like to have updates on our project, you can sign up for our mailing list by emailing us at: email@example.com Thank you and stay safe everyone!