MEadvocacy.org, along with 11 other U.S. ME/CFS organizations representing a vast number of ME patients, have signed a letter sent to officials at HHS calling for investigation into the flawed PACE trial. Among the requests, the letter specifically asks that the CDC remove all recommendations and risk and prognosis statements based on PACE and other Oxford studies from its current and planned medical education material. You can make your voice heard by signing this petition calling for HHS to investigate PACE. Background Recently, journalist David Tuller, DrPH, published an investigative report outlining serious concerns with the conduct, analyses and results of U.K.'s £5 million PACE trial for chronic fatigue syndrome. PACE investigated the efficacy of cognitive behavioral therapy (CBT) and graded exercise therapy (GET). Since then, other researchers and journalists have voiced their own concerns with the fundamental problems in the trial. Most recently, Julie Rehmeyer wrote an excellent overview of the situation in Slate Magazine and six researchers called on The Lancet to "seek an independent re-analysis of the individual-level PACE trial data." PACE is hugely influential globally in how patients are treated in the media, by society and especially in medical practice. In the U.S., various clinical guidelines, including those of the CDC, recommended that ME/CFS patients be treated with CBT and GET, based in part on the PACE trial. In addition, the AHRQ (which is part of the Department of Health and Human Services) published a 2014 evidence review that also recommended CBT and GET, based in part on PACE. The AHRQ Evidence Review can be used to support CBT and GET recommendations in future journal articles and in the clinical guidelines of any country. Such recommendations can harm patients. Therefore, together with 11 other U.S. ME/CFS organizations, we have called on the CDC and the AHRQ to investigate the concerns raised by Dr. Tuller, other researchers and many patients. The letter to Director Thomas Frieden of the CDC and Director Dr. Richard Kronick of the AHRQ can be found here.
If nothing is done, the Social Security Disability Insurance (SSDI) program will become insolvent in late 2016, causing a 19% cut in an already meager payout. This, of course, would be catastrophic for the 11 million people who rely on these payments, including many ME patients. In January 2013, House Republican, Sam Johnson, authored a bill which blocked reallocation of payroll tax revenues from the Social Security retirement fund, precipitating this crisis. http://samjohnson.house.gov/news/documentsingle.aspx?DocumentID=397616 Shuffling Deck Chairs On The Titanic The overall Social Security program is made up of two divisions, a smaller one for disability, and a larger one for old age retirement. Payroll taxes collected from those currently working are divided into two streams, one for SSDI and one for the retirement fund (also called the Old-Age and Survivors Insurance or OASI). Since the 1970s, funds have been reallocated 11 times from SSDI to OASI and vice versa when either fund was in need. This worked fine when, overall, there was enough money to fully fund both. However, due to demographic and other factors, the overall program is projected to become insolvent in 2033. This is 18 years from now - not as far off as it might sound given the time it takes to roll out reforms. While this coming crisis has been projected since 1994, the last time funds were reallocated, it is disconcerting that still nothing has been done about it. The SSDI insolvency crisis is just the first wave of insolvency of the entire Social Security program. Why is SSDI Running Out of Money? In February 2015, the Senate held a budget hearing on SSDI, which can be viewed on Youtube here: https://www.youtube.com/watch?v=4t7CFMBIrl8 The committee reported that there are various factors contributing to the insolvency of SSDI. There have been an increasing number of people receiving SSDI while there is less revenue in payroll taxes coming in. The aging Baby Boomers reaching the prime disability age (70% of disabled workers are age 50+) , and the increase of the number of women in the workforce (and therefore being covered by this program), have caused 1/3 of the increase. People living longer (therefore staying on the rolls instead of dying), and the increase in the age of retirement (shifting more people onto SSDI than retirement) have also contributed. An additional factor is the new disease guidelines implemented in 1984, allowing disability payments for mental illness and musculoskeletal illness (back pain, depression and fibromyalgia are three often mentioned diseases in this category). While heart attack and stroke have remained steady, the incidence in these new diseases has increased, accounting for a whopping 50% of the increase. Note that many ME patients are misdiagnosed as having depression or fibromyalgia, in all likelihood making ME, although hidden, a significant part of this increase. The rates of chronic fatigue syndrome were not mentioned, but it is well known that rates for this disabling disease have increased dramatically since the 1980s. Another factor contributing to insolvency is a loss of revenue from payroll taxes. On the demographic side, the Baby Boomers had less children, so there are less workers paying into the system. Where there used to be 17 workers contributing for every recipient, there are now only 3. The increasing income inequality has also contributed to the problem. There is a cap for workers at wages of $118,000 a year. Those making more do not pay more into the system. As more people are making over this amount, revenue has decreased. Another factor discussed was the economy. In bad economic times such as during the 2008 recession, more people apply for disability, as the ones with impairments are more likely to get edged out in a bad economy. However, there is an offsetting trend with Administrative Law Judges becoming more stringent and actually approving less people. The Acting Commissioner for Social Security, Carolyn Colvin, stated that the only solution for the short term crisis is to let the allocation go through. Everyone present seemed to agree on this point. Kate Lang, co-chair of the Income Security Committee of the Leadership Council of Aging Organizations (LCAO), a coalition of 72 national old age and retirement organizations, spoke on behalf of the disabled to make sure this drastic cut did not happen. However, many Senators stated that while nobody wants to cut funding for the disabled, they will not let a reallocation go through unless there are also reforms to the SSDI program (and possibly OASI) to either cut costs or bring in more revenue or both. Fraud The issue of fraud in the system was discussed. While nobody wants to deny deserving applicants benefits, it was discussed that fraud must be held in check so that funds are available for the truly disabled. News reports from 60 Minutes and NPR in 2013 have left the impression that fraud is rampant in the system. These reports may have precipitated the insolvency crisis and the call to reform. In these reports, Republican Senator Tom Coburn conducted an investigation where he pulled 300 claimants’ case files at random. His team found that 25% of all cases should never have been approved, and another 20% were highly questionable. Back pain, fibromyalgia and depression (all subjective, with no diagnostic tests) are a large part of these cases. There has also been a marked increase in the number of claimants who use lawyers or representatives when they file a claim. In 1971 lawyers were used less than 20% of the time, today, it’s over 80%. If the claim is approved, the lawyer gets paid a fee by Social Security (currently up to $5000). Binder and Binder, a national chain of Social Security Disability representatives, is the largest company making money off the system. Coburn’s investigation turned up an egregious case of a lawyer, Eric Conn, who had allegedly paid off an Administrative Law Judge, David Daugherty, and several doctors to get a 100% approval rate in over 1800 cases in the Huntington, WV area. However, Commissioner Colvin reports that SSDI has several fraud measures in place, such as the Continuing Disability Review program, and that the incidence of fraud is actually extremely low. A study done by the Office of Inspector General reports only a few hundred cases of fraud - a very minimal amount, considering the size of the system. In addition, the 60 Minutes and NPR reports have been criticized by organizations that advocate for and support people with disabilities nationwide. The myths and misleading statements in both reports have been discredited. http://mediamatters.org/research/2013/04/25/myths-amp-facts-behind-the-campaign-to-attack-d/193767#fraud As of 2015, most of the claims against Conn have been dismissed. Earlier this year, Social Security cut off benefits to hundreds of his clients. Later they reversed this decision, but are now requiring Conn’s clients to reprove their cases. There is also evidence that many people who are eligible for benefits are wrongfully denied, as 75% of denied claimants who continue working are unable to earn over the Substantial Gainful Activity amount. This shows a much greater incidence of wrongful denials than fraud in the system, and a giant hole in the social safety net which needs to be addressed. Overall, it is incongruous that Congress is concerned about fraud in the system, yet they don’t fully fund measures to detect fraud. If they fully funded SSDI, they could easily and rapidly detect fraud, reject claimants who aren’t eligible and get truly deserving people their benefits in a timely manner. Currently, it can take up to 2-3 years - a lengthy, confusing, arduous process - to get approved for benefits. What is the Solution? As far as solutions to the insolvency problem and overall reform, various schemes have been proposed. Andrew Biggs, Resident Scholar at the American Enterprise Institute, noted that it’s much easier to keep someone working than to get them back to work once they’ve stopped. Once someone gets on SSDI, less than one half of 1% ever go back to work. The Ticket to Work program, which is available to claimants after they’ve been approved, has essentially been a failure. The Americans With Disability Act has also been a failure. There are actually significantly less disabled people working than before it was implemented. Biggs proposed that work incentives, accommodations and rehabilitation prior to becoming fully disabled be implemented. The idea is to think of disabled people in terms of ability or residual work capacity, instead of incapacity. On the revenue side, Senator Sheldon Whitehouse proposed simply raising the cap on who pays payroll taxes. This would increase revenue enough to keep the system solvent for many years. The hearing didn’t come to any specific conclusions or decisions and it is clear that a lot more discussion and study will be needed, along with pilot programs to test out various ideas for reform. I’m on SSDI - Should I Be Worried? Bottom line, based on the way that Congress works these days, I would expect that the shortfall issue will not be resolved until the last minute. This is conveniently right around the time of the next Presidential election, making it likely to become an issue in this election. In general, Republicans see the fund transfer restriction as a way to force necessary discussion on Social Security finances now instead of kicking the can down the road. Democrats see the Republicans as exaggerating a sense of crisis to have another run at making cuts in Social Security. However, there are enough long term Congress persons around who remember the radical cuts to disability done in the Reagan era, which was one of the most widely criticized policies of that administration. It is unlikely that politicians would repeat that mistake. http://www.nytimes.com/1992/04/19/us/us-to-reconsider-denial-of-benefits-to-many-disabled.html Any reforms would likely be incremental changes, tested first in pilot programs, then rolled out over several years. Those already receiving benefits probably wouldn’t notice any changes except possibly more frequent reviews. Those who are already in the application process, but not yet approved, wouldn’t notice any changes either, as they would apply only to new applicants. As far as ME patients are concerned, it would make a lot more sense to fund ME biomedical research at $250 million per year, than to allow up to 87% of them to become disabled due to no treatment. The average person becomes disabled in their fifties and is awarded a lifetime total of $300,000. Many ME patients become sick at a much younger age than that, making the lifetime payout much larger. Multiply that by the large number of ME patients and you can see where funding research really makes a great deal of fiscal sense. These facts should give ME advocates more ammunition to press NIH for appropriate funding for the disease.
As you may be aware, the documentary, Forgotten Plague, directed by Ryan Prior, has been released. The Huffington Post calls it; “...must see TV, particularly when telling the stories from individuals diagnosed with ME/CFS.” See the full review here - http://www.huffingtonpost.com/bill-johnson-ii/forgotten-plague-a-must-s_b_8230262.html The documentary is now available for private screenings. The screenings are managed by a website called Tugg to make the process easier. If you would like to host a screening (or see if a screening is being held in your area), go to the Forgotten Plague page on Tugg https://www.tugg.com/titles/forgotten-plague You will see two blue buttons on the right side, one for theaters and one for community venues. These are the two types of places where screenings can take place. Theaters Tugg has relationships with major theater chains, as well as independent film houses. You can see what’s available in your area in the drop down list. For a screening at a movie theater, choose the time, date and theater of your choice and then promote your screening with a Tugg Event Page. If enough people reserve tickets, then you'll get your own showing on the big screen! Tugg books the venue and handles all event logistics at NO COST to you - event costs are covered by ticket sales. As long as the event sells enough tickets to make it happen, you can raise additional funds for the charity of your choice, such as the Blue Ribbon Foundation, the Open Medicine Foundation or MEadvocacy.org. In the Fundraising Features section of the registration form, select “Contributions”. You will be able to take contributions on your Tugg event page. Community Venues (Or Even Your Home) For a screening at a community venue, you can coordinate with a community venue such as a library, college campus, community center, or church. You can also hold a house party. Simply purchase the screening license. Tugg delivers the media to you. You have the option to useTugg’s ticketing solution to manage RSVPs, sell tickets, and fundraise for your event. License fees range from $75 for a house party of 1-30 people up to $1500 for a screening of 250-500 people charging admission. There are discounts for screenings done at educational institutions or for not charging admission. Tips and Additional Help Here are 8 great tips for planning a screening, such as having a guest speaker, a link to a media kit, and more: http://us7.campaign-archive1.com/?u=63ebdcb592123884f2316c59f&id=089fbc0671&e=79dbe625e5 If you need additional help, the Forgotten Plague Screenings Team is available to help on the smallest or biggest of issues. The team is available at [email protected] or 478-397-4470.
Image courtesy of Justice for Karina Hansen Article reposted with kind permission from the ME Global Chronicle 10-7-2015 p.102 The charity Save4Children has been created by the editors of the ME Global Chronicle (http://www.let-me.be) and helps parents whose children have been forced into psychiatric wards by authorities, to try and set them free by legal procedures, if the parents have proven to be incapable of affording needed legal assistance. They helped in Joanne’s case – the German teenager who has been held under psychiatric care for 18 months, and Joanne has been allowed to go home last July. Now they would like to help Karina Hansen. Karina is a severely-ill ME patient who has been held in a hospital against her will for 2 ½ years. Her parents are still not allowed to see her. Her condition is worse now than when she was forcibly removed in 2013. She can no longer speak in full sentences. She sits in a wheelchair and mumbles to herself. She is allowed to wear her earplugs as she becomes very distressed when they have tried to take them from her. When she was first taken, she actively resisted treatment and was therefore given the diagnosis of Pervasive Refusal Syndrome (PRS). This is the same diagnosis as Joanne was given. Now Karina no longer resists treatment and the psychiatrists claim that this is improvement. Karina has never resisted eating, which is a core symptom of PRS, so of course this diagnosis is completely ridiculous. Also, Karina is a young adult and PRS is exclusively a pediatric diagnosis. Although it does not look good for Karina at the moment, the fact that “Joanne” has been released gives us hope. Please Donate If you would like to help, please donate to Save4Children. The money that will be donated will be transferred in mutual deliberation to a volunteer non-profit civil rights group called The Citizens Right’s Group (Borgeretsbevægelse) that has taken up Karina’s case. CRG fights for cases that are examples of principle human rights violations and they are finding many violations in Karina’s case. Donation Instructions for English Language Go to the site http://www.geef.nl/doel/save4children Click on “EN” next to the Facebook icon in the upper right corner, which changes site to English translation Click the "Donate Now" button in the right hand column Enter the amount in Euros, and select the payment method (e.g. for USA: Paypal or credit card) Currently: 1 euro = 1.13 US dollars (click here for latest exchange rate) Fill in your name, and address Add a comment "For Karina Hansen" Select the large black “Donate Now” button Further Information About Karina And Her Case Information about Karina and the case can be found in this and future issues of the ME Global Chronicle and at these sites: Justice for Karina Hansen - find info under notes. https://www.facebook.com/JusticeForKarinaHansen Two videos about Karina from 2013: http://www.youtube.com/watch?v=Dk3e8IWj7M0 http://www.youtube.com/watch?v=JTkkcvlvYf8 The Citizen’s Rights Group – documents in the case in Danish http://xn--borgerretsbevgelsen-xxb.dk/ New documents will be added as they become available. Visit the ME Global Chronicle http://let-me.be https://www.facebook.com/groups/TheMEGlobalChronicle/
Graphic by Wendy Boutilier Artz Studio Unbelievable Situation Severe ME sufferer Karina Hansen of Denmark, at the age of 24, was forcibly removed from her home on Feb. 12, 2013 and placed in a psychiatric facility. Karina was officially diagnosed with ME in 2008 after becoming ill with mononucleosis. This was then followed by several infections - a pattern of this illness many of us with ME recognize. Graphic by Michael Evison She was initially held at Hammel Neurocenter despite pleas to have her return home to her family. The family has been barred from contact. In Sept 2014 she was moved to Tagdaekkervej another facility near the Hammel Neurocenter. Even after this move, she has not been allowed to meet with family. More details about Karina’s removal from her home can be found at https://www.thunderclap.it/fr-CA/projects/8739-justice-for-karina-hansen Quote from Justice for Karina Hansen Thunderclap petition Her family and the ME community have tried various routes to resolve this situation, including pursuing legal action in regard to her care and guardianship. In May 2013 an Avaaz petition was circulated asking for “Justice for Karina” as well as a Change.org petition titled “We ask you to allow Karina Hansen to have the right to a second opinion from a leading ME expert Dr Nigel Speight.”. Both of these petitions are now closed. Then in May 2014, The Coalition for Diagnostic Rights sent a letter to Denmark’s Minister of Health: (http://www.diagnosticrights.org/the-coalitions-letter-on-behalf-of-karina-hansen-text-copy/). Thus far these actions have been to no avail. We cannot stand by idly while one of us is so grossly abused. The fact that this atrocity can be happening in 2015 is unconscionable. Please take the actions below and spread this information widely. The world needs to know about this assault on human rights. What Can You Do To Help? For those on Facebook, join the event at: https://www.facebook.com/events/499460126901603/permalink/499464136901202/ "Cards2karina: Hostage of Denmark - 33 months & 3 birthdays deprived of freedom" Send a birthday card to Karina at the facility and another card to her parents. It is unclear as to whether cards sent to Karina will reach her, so sending a card to her parents, as well, insures she will eventually get our well wishes and her parents will know our community has not forgotten their daughter. Because of the situation and Karina’s severe ill health it has been suggested that the envelopes are decorated with cheerful birthday stickers so Karina can tell the envelope contains a birthday card. For those homebound but with computer access, there are websites where a greeting card can be purchased, personalized, and will mail in a nicely addressed stamped envelope. Starting price including local postage is around $3.59, extra for international shipping to Denmark. One example is http://www.cardstore.com/shop/birthday/cards. Karina Hansen c/o Tagdaekkervej 10, 8450 Hammel, Denmark Hansen Family Klovermarken 8, 7500 Holstebro, Denmark Sign the Avaaz Petition - Justice for Karina https://secure.avaaz.org/en/petition/Justice_for_Karina/?email “Karina suffers with severe Myalgic Encephalomyelitis meaning muscle pain with inflammation of the brain and spinal cord. ME is a neurological disease as noted with the World Health Organization (WHO) G93.3. Every country who belongs to the United Nations must abide by the WHO description of what is a physical disease as well as the United Nations Human Rights. Denmark is holding Karina against her will and forcing her to take part in treatment which can kill her. Denmark believes that ME is the same as Insanity which is not how ME is described in WHO G93.3. Denmark is a member of the European Union, United Nations, Human Rights and WHO.”
Abysmally Low Research Funding Despite having officially recognized the best ME definition of any country (the Canadian Consensus Criteria), Canada has almost nonexistent funding for ME, making research difficult. The Canadian group, the National ME/FM Action Network reports the following statistics: There are 756,000 Canadians diagnosed with ME and/or FM. In the fiscal year, 2014-2015, the Canadian federal government funded 54 cents per ME patient for research, and 71 cents per FM patient. Yes, that's pennies, not dollars. (Note - for comparison, the US rate is $5 per CFS patient.) There are more Canadians with ME and/or FM than Canadians with breast cancer, Parkinson's and multiple sclerosis combined. Each breast cancer patient represents $164.00/annum in federal research funding, each Parkinson's patient represents $353.00 in annual funding, and each MS patient represents $73.00 in annual funding. The National ME/FM Action Network has drawn up a one-page summary. As you will note, this brief summary covers a lot of the bases including prevalence, and the abysmal level of research funding, as well as the economic impact of ME and FM. Vote in the Aviva Contest to Raise Money for Research These statistics may look hopeless, but fortunately, there is something you can do to help. The ME (ME/CFS) Fundraising Group has announced that the National ME/FM Action Network in Canada is competing in the Aviva contest for up to $100,000 for ME and FM research. There is both a public voting and a Final judging phase. The top five entries in our category during the voting phase will advance to the judging phase. If they advance, they are guaranteed $5,000 and have a chance of winning $100,000. Last year they did win $5,000. Public voting runs from October 6th (at noon Eastern Standard Time) through October 23rd (at 4 pm EST). Each person gets eighteen votes and can vote once every twenty-four hours. It appears that international voting is permitted again this year. You can register with just your email or via Facebook at www.avivacommunityfund.org. To register, click on the Login button on the top right corner, then select Sign Up. Fill in the required information and submit it. Aviva will send you an activation email. When the email arrives, click “complete your registration” and you should now be good to go. You can register now. When voting begins, just go to www.avivacommunityfund.org/ideas/acf32536 to cast your votes. Prize money will be used to support biomedical research of ME and FM in Canada. You can read more details at the above link. You can receive a daily reminder to vote via email or through Facebook. To receive an email, just send your email request to [email protected] To receive a daily reminder through Facebook, join the event at https://www.facebook.com/events/542552745892932/. Please vote DAILY, share contest information widely, and invite your family and friends to join us in this great effort. Thank you very much for your help!
Fighting for Equitable Treatment for ME Patients Inspired by yet another round of egregious actions of the US Department of Health and Human Services against myalgic encephalomyelitis (ME) patients, MEadvocacy.org was launched a year and a half ago. We have approached advocacy in a creative way, utilizing technology to our advantage. In particular, for our website, we’re using the Nationbuilder platform – a technology purpose-built for advocacy. Accomplishments Since our last fundraiser, we have: Represented ME at both the House and Senate NIH Budget Appropriations meetings this past April. Contacted key members of Congress and their staffers were contacted in person and by phone. Disseminated specially prepared information packets were distributed to key members of the Appropriations Committees. Conducted two successful demonstrations in Washington DC. One in March and the other in April of this year. Patients were represented by university students who wore the patients’ pictures and read off their bios at the Mall. Issued 2800 letters to Congressional representatives via the One Click app. Posted 18 blogs outlining our activities as well as pertinent information and news crucial to the community. Raised awareness about NIH's misinformation about the denial of funding to scientists trying to study ME. Testified at the CFSAC August 2015 meeting both orally and in writing. Grown our membership - we currently have 1,180 members. Revamped our home page has a whole new look. The aim is to appeal to newcomers and those in the general public who have very little knowledge, if any, of ME. Future Goals We plan to once again participate in the Budget Appropriations process starting early in 2016. This time we will be addressing the CDC as well as the NIH, so that a repeat of this past year’s attempt at deletion doesn’t recur because the powers that be don’t think that ME is serious or worth consideration. We will continue our efforts to spread ME awareness outside of the “patient bubble” and into the general community. We believe this is crucial to get a critical mass that will have positive results for ME patients. Who Runs This Site and What Does It Cost Our funds for website operations, raised a year ago, are starting to run low. As the membership has grown, so have monthly operating expenses. In particular, we desire to run the One Click Politics app every month, instead of just 3 to 4 months out of the year, in order to keep up the pressure on Congress. So now it’s your turn to step up to the plate. If you believe this website is a valuable resource and wish for us to continue assisting patients and stakeholders like you with advocacy and awareness for ME, please donate. Our goal is to raise $2300, which will keep the site running for the next 12 months* *As per our agreement with May12.org, our fiscal sponsor, 10% of that amount will go to May12.org to cover accounting costs. As May12.org is a 501(c)(3) non-profit, all donations are tax deductible. Both sites are run by patient volunteers, with none of the waste on salaries, buildings, and overhead associated with the large patient organizations. We are not affiliated with any government agency, and operate independently. Please Donate Our goal is to raise $2300 by Sunday, October 18, 2015 at midnight Eastern Daylight Time. Matching Donations, ME Wristbands and More... A generous donor has pledged to match the first $1,000 in donations, so donate now and double your amount! If you make a donation of $50 or greater, you will receive 2 ME wristbands as shown in the photo (kitten not included). In addition, if you make a donation of $1 or greater, you can submit a name for the kitten pictured. The kitten’s mother was pregnant when rescued by one of our volunteers. The young male pictured is the lone survivor of that litter. He’s a real fighter and needs a name. Make your suggestion in the comments section below this blog article. Names submitted without a donation will not be considered.
Image captured from video provided by Open Medicine Foundation One Mission: To Figure Out This Disease NIH Deception The deception emanating from the National Institute of Health (NIH) is that ME/CFS funding is a priority for them. They really want to fund our research but 1) there are too few applications coming in to them and 2) they are of poor quality. The fact is the ME community has been lucky to have recently attracted world renowned scientists to the field. These scientists have had their applications for NIH funding for their studies returned unapproved. NIH has approved countless applications for studies from these same scientists, as long as it was not ME/CFS related. Could it be that the famous virus hunter, Dr. Ian Lipkin as well as Dr. Mady Hornig, suddenly lowered the quality of their application when it came to ME? Did Dr. Ronald Davis, the award winning inventor with decades of NIH funded research, abruptly lose his brilliance to be graded “not that great” by the application reviewer? “If There Were Meritorious Applications, We Would Fund Them” - Cheryl Kitt (NIH) Cheryl Kitt presented at the August 18, 2015 CFSAC meeting regarding approving application for research funding from the NIH. Which of the following statements do they expect us to believe? There are too few applications for research in ME/CFS. We only fund the best science applications. If they were meritorious applications, we would fund them. I have to tell you; they are not that great. ME/CFS is a high priority for us. We won’t just throw money out there. It’s not that we don’t want to fund, we would if the applications were there and meritorious that pass review. The Open Medicine Foundation and Ron Davis: World renowned board member of the Open Medicine Foundation (OMF), Dr. Ronald Davis, is a professor of Biochemistry and Genetics at Stanford University School of Medicine and he is the director of the Stanford Genome Technology Center. As part of the End ME/CFS Project, Dr. Davis has started the project's first study; the ME/CFS Severely Ill, Big Data Study. This is the first study looking directly at the Severe ME patients, designated to find a clinically useful diagnostic biomarker. Many distinguished scientists make up Dr. Davis’ team. Some are actual Nobel Prize Laureates, such as Drs. James D. Watson, Mario Capecchi and Paul Berg, They are on the OMF’s ME/CFS Scientific Advisory Board, which determines what studies are conducted in this project, and are investing their unique expertise into solving the problem of our modern time hidden plague. Dr. Davis was named among the top 7 of “Today’s Greatest Inventors”, Atlantic Magazine (2013) and Inventor of the Year, SVIPLA 2011 among the list of twenty distinguished awards earned throughout his career. Dr. Davis and his family struggle with his son’s illness. Davis' son, Whitney, has a severe form of ME and recently appeared in a mini-documentary. This video tells the heart-rending story of how Dr. Davis and his wife care for their son 24/7 with selfless love. The documentary also highlights two other ME patients with their treating doctor, Andy Kogelnik. Recent generous donations have provided funds to begin this historic project, but these studies are expensive. Their goal is $5 million per year for the “End ME/CFS” project. This September 1, 2015 letter signed by Ron Davis and other renowned scientists underscores the difficulties they have had in securing funding from the NIH. Dr. Ron Davis on What Needs to Be Done: Dr. Davis is featured in this video calling NIH out for their rejection of his research application for his Big Data Study using a cohort of the most severe ME patients. Please take the time to listen to the full video. It is full of valuable gems such as Unity and Cooperation While promoting cooperation with other researchers, Davis discusses “Harvard Mode” - in order to have good research, you have to have a competitor. He counters that premise with “There is One Mission: To figure out this disease.” “It is like a startup, where everyone needs to pull their weight. Everyone works together, everyone shares and they have one mission - to make the company succeed.” Accomplish Advancement "Take a collection of patients and collect more data on them than has ever been collected on a human being before." “..with severe patients, we expect the signal to be larger - this will give us a statistical difference.” Referring to his son: "The standard medical procedures that a doctor will run liver function... are fine. But if you look deeper he's not fine... we've found several hundred things that are actually out of whack in his system." “let’s share the data and see what we can do about this disease” “Sometimes, you don’t need to understand the disease to actually cure it! This can be done by accidental observation like noticing that treating patients with Rituximab for lymphoma made ME patients better. Taking note of that is important… This resulted in clinical trials going on right now to treat this disease.” “We need random observation.” "I'm convinced this disease is really treatable." "I'm very optimistic. We are on a very rapid change because of technologies..." NIH Involvement and Funding "We have to get NIH involved and that's going to take some level of pressure. That pressure can come from the public and it can also come from congress." What You Can Do: Donate to the Severely Ill Big Data Study here Tell congress we need $250 million in funding, the historical name ME and ME criteria here Tell Congress that we need a champion to stand up for ME patients here. Sign this ME Action campaign created by Ruddy Red to request that Francis Collins, Director of NIH, authorize a new RFA (Request for Application) for ME/CFS Like and Share this blog on Facebook, Twitter and Google+ to spread the word
As most of you know, the Chronic Fatigue Syndrome Advisory Committee (CFSAC) held their bi-annual meeting on August 18 and 19, 2015. What IS CFSAC: CFSAC, formerly known as the Chronic Fatigue Syndrome Coordinating Committee, was established September 2002. CFSAC is governed by the provisions of the Federal Advisory Committee Act. Its purposes include advising and providing recommendations to the Secretary of Health and Human services. through the Office of the Assistant Secretary for Health (ASH), on issues related to research, access and care for individuals with ME/CFS. The committee is comprised of eleven voting members (including the chair). These include expert researchers, doctors, nurses, insurance specialists and a patient advocate. The current voting members are: Susan M. Levine, M.D. (chair) Adrian M. Casillas, M.D. Rebecca Patterson Collier, R.N., CCM Dane B. Cook, Ph.D. Lisa W. Corbin, M.D. Mary Ann Fletcher, Ph.D. Gary E. Kaplan, D.O. Alisa E. Koch, M.D. Jose G. Montoya, M.D. Faith Newton, Ed.D Donna M. Pearson (patient advocate) The committee also consists of seven non-voting ex-officio members. They include representatives of the following agencies: Agency of Healthcare and Quality (AHRQ), Centers for Disease Control and Prevention (CDC), Center for Medicare and Medicaid Services (CMS), Food and Drug Administration (FDA), Health Resources and Services Administration (HRSA), National Institutes of Health (NIH), Social security Administration (SSA). In addition, the committee presently includes two non-voting liaisons representatives: Solve ME/CFS Initiative (SMCI) - represented by Carol Head International Association for chronic fatigue syndrome/myalgic encephalomyelitis (IACFS/ME) - represented by Steven Kraftchick, MPH, JD The committee meetings are supervised by the Designated Federal Officer (DFO) - represented by Nancy Lee, M.D. The DFO assures coordination and communication between CFSAC and the HHS agencies The August Meetings: The two day meeting was packed with important data, parsing the two recent reports of the IOM and P2P. CFSAC had assigned a workshop led by patient advocate, Donna Pearson, to review and create recommendations based on these two reports. The workshop spent a lot of time and effort delving deeply into the details of the reports. The workshop members presented sixteen recommendations to the committee. These were discussed and voted on by the seven voting members who were present. Fifteen of the recommendations were passed. The one recommendation they could not agree on, was about the name change. Some voting members voted for the IOM suggested name of systemic exertion intolerance disease (SEID). Others pushed for the historical name myalgic encephalomyelitis (ME). They decided to shelve this topic for a later date. The next stage for these recommendations is the process of being reviewed by the various government health agency departments. Then, it will go to Secretary Burwell. This process is expected to take several months. We hope to bring you a response about this two day meeting after we have reviewed the official CFSAC minutes and videos. Our Oral Testimony: On August 19th My name is Colleen Steckel. I represent MEadvocacy.org, a non-profit patient advocacy group managed by patient volunteers with eleven hundred members. Our focus is to advocate for awareness of Severe ME and the urgent need for research and funding. We promote the name Myalgic Encephalomyelitis. We call for ME to be officially recognized as its own distinct disease separate from CFS, under the ICD-10-CM code G93.3, along with a strictly defined ME definition using the Canadian Consensus Criteria, the International Consensus Criteria or better. Our organization fills a great need brought on by years of neglect and malfeasance by our government health agencies. This neglectful abuse has produced a hidden and growing plague affecting at least one million American men, women and children causing lifelong disability and extremely poor quality of life. Despite the good intentions of the CFSAC committee, the outcome has been ineffectual because the government has declined recommendations, erased some parts they didn’t like and totally misrepresented others. We were appalled to witness Health and Human Services pervert the 2012 CFSAC recommendation to redefine the disease starting with the CCC. This corruption as well as the refusal to heed the call of ME experts resulted in a waste of a million dollars only to produce a product inferior to the experts’ recommendations. We submit that the suicides we have witnessed since that date may be a direct result of the despair of patients caused by this abuse of power. According to Leonard Jason and others, the IOM name and definition is no better than the inadequate Fukuda definition. Our trust has been shaken again by the reinstatement of the same DFO, Nancy Lee who allegedly threatened three voting members and is suspected of altering recommendations. CFSAC’s charter states that this committee was created to HELP patients - yet, patients feel unheeded and maltreated. If “help” is what was intended, this has been an epic fail! What do we want? Nancy Lee replaced with someone who will regain the confidence of the ME community. Implement CFSAC recommendations without further delay with emphasis on getting a primer based on the ICC and/or CCC into the hands of physicians as quickly as possible. Include the needs of Severe ME patients in every discussion. $250 Million in funding for biomedical research Answers why funding requests from researchers in our field keep being denied and a plan to remove those roadblocks. Thank you for your time. Our Written Submission: RE: Request for input for CFSAC meeting to be held Aug. 18-19, 2015 MEadvocacy.org is a non-profit patient advocacy group focusing on advocacy and raising awareness of severe ME. We promote the name Myalgic Encephalomyelitis along with the ME criteria authored by ME experts. Our organization is growing rapidly and is currently 1,100 members strong. MEadvocacy.org is filling a great need resulting from our government’s long time neglect and malfeasance. This neglectful abuse has produced an outgrowth of a hidden plague affecting at least one million American men, women and children causing lifelong disability and extremely poor quality of life. While it may be that some members of the CFSAC committee have served with good intentions and have ME patients’ best interests in mind, the committee overall has sadly been ineffectual. Moreover, the malfeasance by the government health agencies, in either declining every recommendation or wrongfully altering them, has resulted in no advances in the care and treatments of those suffering from this disease for over 30 years. In 2004 the following recommendations were made: September 27, 2004 We would urge the DHHS to direct the NIH to establish five Centers of Excellence within the United States that would effectively utilize state of the art knowledge concerning the diagnosis, clinical management, treatment and clinical research of persons with CFS. These Centers should be modeled after the existing Centers of Excellence program, with funding in the range of $1.5 million per center per year for five years. We would urge the DHHS, through the NIH, expedite the issue of an RFA with sufficient set aside funds to attract senior level researchers to engage in the study of CFS. DHHS should fund extramural grants, reviewed by a special emphasis panel knowledgeable CFS, through ROl, R03, P.21, and Directors Pioneer Award mechanisms. The DHHS should provide funds to develop an international Network of Collaborators that would allow for multidisciplinary CFS-related research using standardized criteria accepted by the international CFS research community. Such a network would pool large number of patients from around the world, and would require investigators to develop and employ common protocols. DHHS should provide support and funding for an intramural staffed laboratory committed to CFS research. Eleven years later there is no evidence these recommendations have been considered or effectively implemented. June 2012: 1. CFSAC asks that the Centers for Disease Control and Prevention (CDC) remove the CFS Toolkit (both English and Spanish versions) from the CDC website. 2. CFSAC asks that the appropriate person[s] within HHS work with the International Association for Chronic Fatigue Syndrome/Myalgic Encephalomyelitis to make their primer widely available, particularly to primary care providers. 3. CFSAC asks that HHS staff work with Committee members to develop a list of ME/CFS organizations and criteria for posting links to the organizations’ websites on the CFSAC website. 4. CFSAC asks that a link be added to the CFSAC website for the Department of Education-supported Parent Technical Assistance Center Network. 5. CFSAC asks that HHS partner with Committee members and the Department of Education to educate educators and school nurses on ME/CFS affecting children and adolescents. Three years later patients are still struggling to find educated physicians despite the recommendation that HHS make the IACFS/ME Primer widely available. We were appalled to witness the perversion of the March 2014 CFSAC recommendations. Alterations included the omission of references to the Canadian Consensus Criteria. Details about this incident can be found at: http://www.occupycfs.com/2014/11/24/another-cfsac-violation/ This corruption as well as the refusal to heed the call of ME experts to adopt the criteria the experts recommend resulted in a waste of a million dollars only to produce an inferior product. We submit that the suicides we have witnessed since that date may be a direct result of the despair of patients caused by this abuse of power. The resulting new IOM name has been found to be no better than the degrading moniker “CFS” as well as the inadequate Fukuda definition according Leonard Jason and others. This is inexcusable, when we already have the Canadian Consensus Criteria (CCC) and the International Consensus Criteria (ICC) authored by ME experts which better defines the authentic disease ME. In addition, we do not feel confident that the voting CFSAC members are free to act and speak on their own accord. There were allegations by voting members; Eileen Holderman, MaryAnn Fletcher and one more member that they were threatened by the DFO, Nancy Lee, when questioning the route that CFSAC was taking regarding this recommendation. Patients have lost all confidence in the efficiency and autonomy of the CFSAC voting panel. Our comfort level has been shaken again by the reinstatement of the same DFO, Nancy Lee. We feel Nancy Lee must be replaced with someone who will work for the well-being of patients in order to restore credibility in the ME community. CFSAC’s charter states that this committee was created to HELP patients. But instead patients feel unheeded and maltreated. If “help” is what was intended, this has been an epic fail! We call for ME to be officially recognized as its own distinct disease separate from Chronic Fatigue Syndrome, under the ICD-10-CM code G93.3, along with a strictly defined ME definition using the Canadian Consensus Criteria, the International Consensus Criteria or better. We call for NIH funding for ME be raised to at least $250 million, an amount on par with similar diseases such as MS. We also demand that all research funding be spent on the biomedical aspects of ME and that severe ME patients be studied. In addition, we demand that grant reviewers familiar with ME be used, as even excellent proposals from world renowned researchers such as Ian Lipkin and Ron Davis are being denied. We, at MEadvocacy.org anxiously await some real action to help stop the neglect and malfeasance of those of us suffering from Myalgic Encephalomyelitis. MEadvocacy Advisory Group Mary Ann Kindel Tracey Temple Smith Colleen Steckel Gabby Klein Joni Comstock Kathryn Stephens Edit - One click option letters to congressional representatives is currently closed.
The next meeting of the Chronic Fatigue Syndrome Advisory Committee is this week Tuesday, Aug 18 and Wednesday August 19, from 9am - 5pm EDT (Eastern Daylight Time). Sessions regarding the recent Institute of Medicine and Pathways to Prevention redefinition projects are on the agenda. We also hope to hear something about the recent proposal to defund CFS at the CDC, and the speculation of CFS moving out of the Office of Womens' Health to NINDS (an institute with a much bigger budget). Agenda - http://www.hhs.gov/advcomcfs/meetings/agendas/cfsac20150818-agenda.html.htmlMEadvocacy.org will be making an oral presentation on Wednesday during the public comments (10-11am). You may watch the live video stream here http://www.hhs.gov/live-1/, or access the listen only toll free teleconference line at dial 888-455-5629, passcode: 9717791#