Wednesday, August 26, 2015

An Open Letter from Researchers to Senator Mikulski: Patients suffering from ME/CFS deserve funding

The woeful state of funding for ME/CFS is so dire that two HHS-funded initiatives, the IOM and the P2P, have taken pains to point it out.

The IOM committee stated that “Remarkably little funding has been made available” to study this disease, and “More research is essential.” The P2P, a report sponsored by the NIH, came to the same conclusion.

Limited knowledge and research funding creates an additional burden for patients and health care providers. 
There are few disease-specific clinical trials; a disconnect on ways patients, clinicians, and researchers define meaningful outcomes; a lack of well- 4 controlled, multifaceted studies using large, diverse samples; and limited public and private research dollars directed at ME/CFS. 
Current research has neglected many of the biological factors underlying ME/CFS onset and progression. 
Overall, there has been a failure to implement what we already know for ME/CFS patients while the disease steals their health and well-being. Scientifically rigorous research is needed to improve this situation... Innovative biomedical research is urgently needed to identify risk and therapeutic targets.
In spite of this urgent need - stated in unequivocal terms by reports sponsored by HHS - the NIH has repeatedly denied funding to researchers who have a solid track record. Ron Glaser, President of the PsychoNeuroImmunology Research Society (PNIRS) and recognized as one of the world's most cited authors in his field, was turned down. Nancy Klimas, whose Gulf War research was funded, has been repeatedly rejected. Ian Lipkin, the world's foremost virus hunter, was rejected, as was Ron Davis, who was named among the top 7 of "Today's Greatest Inventors" in 2013 and is winner of numerous prestigious prizes.  

Nobody in their right mind could claim that these researchers did not know how to conduct meritorious research when they submitted their proposals. Yet, at the most recent CFSAC meeting Cheryl Kitt, Deputy Director of the Center for Scientific Review at NIH, claimed that there aren’t many people interested in researching ME/CFS and that the NIH hasn’t received applications of sufficient quality.

In answer to that specious claim, some of the top researchers in the field have written an open letter to Senator Mikulski (D- Maryland). Mikulski is chair of the Senate Appropriations Committee.

Read more about the push for increased NIH funding in this excellent article:

Lobbyists seek new funds for chronic fatigue syndrome research


August 17, 2015

Dear Senator Mikulski,

We the undersigned scientists are writing to express our interest and enthusiasm for researching myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), a common and disabling illness long ignored by our nation’s health agencies.

Many of us have had a very difficult time securing adequate funding. Others have been unable to determine even how to apply for funding, as no institute within the NIH has responsibility for researching ME/CFS. The NIH has responded to requests for increased funding by stating that few researchers are interested in studying the illness.

On the contrary there are Nobel Laureates, several members of the National Academy of Sciences, biochemists, biophysicists, geneticists, immunologists, neuroscientists, experts in public health and infectious disease, epidemiologists, and physicians eager and ready to study this disease, were adequate funding made available. The undersigned are just some of those researchers.

We have so much to learn and large studies are needed to understand how to help patients regain their health. With societal costs in the tens of billions of dollars each year, an infusion of government funding could quickly repay that investment.

Currently, ME/CFS is massively underfunded compared to other diseases of similar severity and number of patients. The NIH allocates just $5 million per year to study this illness, which affects between 836,000 and 2.5 million Americans. Patients suffering from ME/CFS deserve funding proportional to and commensurate with other diseases with similar patient populations. The Institute of Medicine, a special HHS advisory committee, and a recent NIH­-appointed expert panel all agree: It is imperative to increase research funding for ME/CFS.

If invited to apply for NIH funding via a new Request for Applications (RFA), we would eagerly submit grant proposals.

Linda Tannenbaum, Executive Director, Open Medicine Foundation

Scientific Advisory Board:

Ronald W. Davis, Professor of Biochemistry and Genetics, Stanford University School of Medicine, Member of the National Academy of Sciences

Paul Berg, Nobel Laureate in Chemistry, Professor emeritus of Stanford University

Mario R. Capecchi, Nobel Laureate in the Physiology or Medicine category, Professor of Human Genetics at University of Utah School of Medicine, Member of the National Academy of Sciences

Mark M. Davis, Professor of Microbiology and Immunology at Stanford University School of Medicine, Director of Stanford Institute for Immunity, Transplantation and Infection, Member of the National Academy of Sciences

H. Craig Heller, Professor of Biology at Stanford University

Andreas M. Kogelnik, Physician­, Scientist, Founder and Director of the Open Medicine Institute

Baldomero M. Olivera, Biology Professor at the University of Utah, Member of the National Academy of Sciences

Ronald G. Tompkins, Professor of Surgery at the Harvard Medical School, Chief of Trauma, Burns and Surgical Care Service at the Massachusetts General Hospital, Chief of Staff at the Shriners Hospitals for Children in Boston

James D. Watson, Nobel Laureate in Physiology or Medicine, Chancellor of Cold Spring Harbor Laboratories, Member of the National Academy of Sciences

Wenzhong Xiao, Assistant Professor of Bioinformatics at Harvard Medical School, Director of the Inflammation & Metabolism Computational Center at Massachusetts General Hospital

Susan Levine, MD Researcher and Clinician, Private Practice New York, New York Visiting Fellow, Cornell University Ithaca, New York

Peter C. Rowe, MD, Professor of Pediatrics, Director, Pediatric Chronic Fatigue Clinic, Johns Hopkins Children’s Center, Maryland

Alan R. Light, PhD, Professor, Department of Anesthesiology and Department of Neurobiology and Anatomy, University of Utah, Salt Lake City, Utah

Kathleen C. Light, PhD, Researcher, Professor, Department of Anesthesiology, University of Utah School of Medicine, Salt Lake City, Utah

Zaher Nahle, Phd, MPA, Vice President for Research and Scientific Programs, Solve ME/CFS Initiative, California

Leonard A. Jason, PhD Professor of Psychology DePaul University Chicago, Illinois

Derek Enlander, MD, MRCS, LRCP Attending Physician Mount Sinai Medical Center, New York ME CFS Center, Mount Sinai School of Medicine New York, New York

David L. Kaufman, MD, Medical Director, Open Medicine Institute, California

Staci Stevens, MA, Exercise Physiologist, Founder of Workwell Foundation, California

Jared Stevens, BS, Clinical Coordinator, Workwell Foundation, California

Dorothy Hudig, PhD, Professor of Immunology, Department of Microbiology and Immunology,
University of Nevada School of Medicine Reno, NV

Patrick O. McGowan, PhD, Assistant Professor, University of Toronto Scarborough Centre for Environmental Epigenetics and Development (CEED) Department of Biological Sciences Cell
and Systems Biology, Psychology, Physiology Toronto ON

Marcie Zinn, PhD, Neuroscientist, DePaul University Chicago, Illinois

Mark Zinn, Co Founder, NeuroCognitive Research Institute, Dublin, CA

Jarred Younger, PhD, Associate Professor, Departments of Psychology, Anesthesiology, and Rheumatology, University of Alabama at Birmingham

David Maughan, PhD, Professor of Molecular Physiology & Biophysics, Emeritus, University of Vermont School of Medicine Burlington, VT

Wednesday, August 19, 2015

ME Action Calls for Funding Equality

In light of the recent CDC funding cut for ME/CFS, ME Action's call for equal funding is both timely and urgent.

Along with Mass CFIDS Association Board members, I am meeting with Elizabeth Warren's staff on Thursday. I urge all of you in the target states (see below) to contact your representatives.

These meetings can be done by phone, and by several people simultaneously.

There are two messages: Increase funding commensurate with impact of the illness, and move ME/CFS from the Office of Research on Women's Health (which gets no funding), to the National Institute of Neurological Disorders and Stroke.

This is a representative democracy. Let's get represented!
#MEAction recently launched as an online platform to help anyone become an advocate.
Now we are announcing our own advocacy action: A quick-strike lobbying campaign to spur the US Congress to vastly increase research funding for ME/CFS at the National Institutes of Health.
We launched this effort to capitalize on the 21st Century Cures Act, which would give the NIH an extra $8.75 billion over five years. The House of Representatives passed the bill earlier this summer, and the Senate is now considering the bill. Currently, the NIH allocates just $5 million per year of its $31.3 billion budget to study ME/CFS.

This moment is crucial – key senators on the HELP committee can add provisions to the bill before they vote.


To that end, we have retained a well-connected consultant who previously worked for the Senate Finance Committee and helped pass key provisions of the Affordable Care Act. This consultant is now meeting with important Senate staffers, and patient advocates are calling into those meetings to present our two-point “ask”:
  • NIH will establish authority for researching ME/CFS within the National Institute of Neurological Disorders and Stroke (NINDS).
  • NINDS will establish an intramural and extramural ME/CFS program, funded at levels comparable to illnesses with similar patient numbers and economic cost to society.
Getting this language written into law would be a major victory for ME/CFS patients and allies. Our early experience suggests that key Senate staffers are open to this message. There’s a lot of work still to be done, and the outcome is uncertain. But one thing is certain: We will make progress by repeatedly sending this consistent message to Congress.
You can download our “one-pager” that we are using to present our case here.


We still need help from patient advocates willing and able to call into 30-minute meetings on Capitol Hill from the following states and Congressional districts:
  • Alaska (all)
  • Kansas (all)
  • Kentucky (all)
  • Louisiana (all)
  • Michigan (Midland, Saginaw Township, Mount Pleasant, Owosso, Thomas Township, Bridgeport Township, Big Rapids and Alma)
  • New Jersey (New Brunswick, Perth Amboy, Sayreville, Piscataway and Asbury Park)
  • Wyoming (all)
If you live in any of those locations and would like to join the effort, please sign up here.
No matter where you live, sign the US funding equality petition and help us take the petition to the streets.


In the coming weeks, we will be enlisting the entire community’s help to speak to Congress in one, loud voice through a coordinated campaign. In the meantime, we need your help to make this endeavor a success. The huge lobbying efforts for Alzheimer disease, Parkinson disease, and other major diseases spend millions of dollars each year trying to reach Congress.
Please donate today. Consider making it a recurring donation. Your contribution, no matter how small, will help us bring the future here faster.


Monday, August 10, 2015

Ampligen to Be Supplied Throughout Europe As Well As Turkey

Hemispherx Biopharma's agreement to supply Ampligen to ME/CFS patients in Europe could not have come at a better time.

 recent paper by a group of downstate New York psychiatrists made headlines when it proposed that fibromyalgia and CFS (among others) should be placed on the spectrum of anxiety disorders.

The agreement to use an immune modifier to treat ME/CFS underscores the position stated in the IOM report that this is not a psychogenic disease, much less an anxiety disorder.


Hemispherx Enters Into an Agreement With myTomorrows for an Early Access Program for Rintatolimod in Europe

Press Release: PHILADELPHIA, Aug. 10, 2015 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE MKT: HEB) (the "Company" or "Hemispherx"), reported today that it has executed an agreement with Impatients, N.V., a Netherlands based company doing business as myTomorrows, for the commencement and management of an Early Access Program (EAP) in all of Europe and Turkey.

myTomorrows, as Hemispherx' exclusive service provider in Europe and Turkey, will perform EAP activities in Europe and Turkey to include the supply of rintatolimod for the treatment of Chronic Fatigue Syndrome (CFS) to patients with an unmet medical need.

Govert Shouten, Ph.D, Co-Founder & CBO at myTomorrows, said "Rintatolimod for CFS fits perfectly with the raison d'ĂȘtre of myTomorrows. CFS affects as many people in Europe as in the US and there is no drug approved anywhere specifically for CFS. In clinical trials rintatolimod has shown promising results for certain CFS patients particularly those most severely affected.

As we do with other life-threatening and debilitating diseases such as cancer, MS, and depression, myTomorrows will set up and roll out the early access programs needed to help these patients.

Thomas K. Equels, Executive Vice Chairman and CFO of Hemispherx said "We are very pleased to be collaborating with myTomorrows to provide rintatolimod under these unique Early Access Programs. Not only will this collaboration create the possibility for physicians to use rintatolimod under certain circumstances, myTomorrows will collaborate with these physicians to capture data on patients treated and such data may add to our other efforts to gain full regulatory approval in Europe, Latin America, Australia, New Zealand as well as the U.S. and elsewhere."

myTomorrows was founded by physicians and experts from the pharmaceutical industry who want to facilitate early access to developmental drugs for patients with high unmet needs. Ronald Brus, M.D., was the former CEO of Crucell, a vaccine company acquired by Johnson & Johnson for $2.4 billion in 2011. Govert Shouten was previously Vice President, Business Development at Crucell.

About Rintatolimod

Rintatolimod is a member of a new class of specifically-configured ribonucleic acid (RNA) compounds targeted as potential treatment of diseases with immunologic defects and/or viral causation.

About myTomorrows

myTomorrows provides patients that are excluded from clinical trials access to drugs in development. They focus on disease areas with unmet needs; oncology, neurology, psychiatry and rare diseases. myTomorrows identifies the latest developments in drugs and facilitates requests for access to these drugs in development. Their physicians and bio-medical specialists identify the latest drug developments from across the globe. Physicians and pharmacists can register online and request information about the drugs myTomorrows provides access to. In most countries health authorities must grant permission for treatment with a non-registered drug. myTomorrows facilitates requests for permission for physicians and pharmacists.

About Hemispherx Biopharma

Hemispherx Biopharma, Inc. is an advanced specialty pharmaceutical company engaged in the manufacture and clinical development of new drug entities for treatment of seriously debilitating disorders especially life-threatening viruses. Hemispherx's flagship products include Alferon N Injection® and the experimental therapeutics rintatolimod and alpha interferon LDO. Rintatolimod is an experimental RNA nucleic acid being developed for globally important debilitating diseases and disorders of the immune system, including Chronic Fatigue Syndrome. Hemispherx's platform technology includes components for potential treatment of various severely debilitating and life threatening diseases including cancers.

Disclosure Notice

The information in this press release is intended solely for the United States and includes certain "forward-looking" statements including without limitation statements about additional steps which the FDA may require and Hemispherx may take in continuing to seek commercial approval of rintatolimod for the treatment of Chronic Fatigue Syndrome in the United States and abroad. The final results of these and other ongoing activities could vary materially from Hemispherx's expectations and could adversely affect the chances for approval of the rintatolimod in the United States and other countries. Any failure to satisfy the FDA regulatory requirements or the requirements of other countries could significantly delay, or preclude outright, approval of rintatolimod in the United States and other countries including Australia and New Zealand.

Information contained in this news release, other than historical information, should be considered forward-looking and is subject to various risk factors and uncertainties. For instance, the strategies and operations of Hemispherx involve risk of competition, changing market conditions, changes in laws and regulations affecting these industries and numerous other factors discussed in this release and in the Company's filings with the Securities and Exchange Commission. The final results of these efforts could vary materially from Hemispherx's expectations. No evidence has suggested that rintatolimod will ever be commercially approved for the new potential treatment indications, including, but not limited, to the treatment of CFS.

Forward-Looking Statements

To the extent that statements in this press release are not strictly historical, all such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Words such as "intends," "plans," and similar expressions are intended to identify forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation by Hemispherx that any of its plans will be achieved. These forward-looking statements are neither promises nor guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond Hemispherx's control, which could cause actual results to differ materially from those contemplated in these forward-looking statements. Examples of such risks and uncertainties include those set forth in the Disclosure Notice, above, as well as the risks described in Hemispherx's filings with the Securities and Exchange Commission, including the most recent reports on Forms 10-K, 10-Q and 8-K. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Hemispherx undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise revise or update this release to reflect events or circumstances after the date hereof. No evidence is suggested that rintatolimod will ever be commercially approved for the CFS treatment indications mentioned in this release into USA or other countries.

Friday, August 7, 2015

Federal Government Slashes ME/CFS Funding to Zero

In an almost incomprehensible move, funding for ME/CFS has been eliminated entirely from the 2016 CDC budget. Both the IOM and the P2P reports - initiatives funded by the Federal government - stressed the woeful underfunding of ME/CFS and called for more research. Yet, the Federal government has responded by cutting funding completely.

Please take a moment to copy and paste the sample email below. Send it to:;;;

If you live in Massachusetts please fill out the contact form for Elizabeth Warren. You can find it here:
Send her this note:

Subject: Please restore CDC funding for Chronic Fatigue Syndrome

I understand that the Senate Appropriations Committee has recommended that funding for the CDC’s programs for Chronic Fatigue Syndrome be terminated as of 2016.

I am a patient with Chronic Fatigue Syndrome (CFS), also known as Myalgic Encephalomyelitis or ME/CFS. The Institute of Medicine has just issued a major report on this “serious, chronic, complex, multisystem disease” citing the devastation on the lives of the 836,000 to 2.5 million Americans who suffer from this debilitating disease, the $20 billion annual cost to society, and the enormous need for more research which can lead to better treatments and a cure. We need MORE money for research, medical education, and information for patients and their families, NOT a termination of support.

I urge you to reinstate the $5.4 million funding for the CDC/CFS programs immediately.

Reprinted from the Solve ME/CFS Initiative Website

Reinstate Federal Research Funding for ME/CFS

Please act now! The $5.4 million in CDC funding for ME/CFS has been stricken from the Senate’s version of the 2016 federal budget. As you can see from the graphic below, ME/CFS was the only disease to be reduced to $0.

You have an opportunity to directly impact federal funding for ME/CFS by sending an email to the four key staff members who serve the Senators on this budget committee:;;;
Please take a moment to send them an email asking that the funds be reinstated immediately. We have posted a draft letter here for you to use. Feel free to revise as it suits you but note that time is of the essence. We need to have the emails sent within the next week to have any chance at reversing this decision and preserving our much-needed funding.

Dear Senator:

I am writing to urge you to reinstate the $5.4 million for Chronic Fatigue Syndrome funding. This is included in the CDC budget under Emerging and Zoonotic Infectious Diseases, on Page 59 of the Senate Budget.

I understand that the $5.4 million in funding submitted by the Centers for Disease Control for Chronic Fatigue Syndrome has been stricken from the 2016 appropriations bill by the Senate Appropriations Committee. This is an appalling act of inhumanity, and I urge you to reinstate the $5.4 million amount into the 2016 budget without delay.

As you may be aware, the prestigious Institute of Medicine of the National Academies published a landmark report on Myalgic Encephalomyelitis/Chronic Fatigue Syndrome on Feb. 10 of this year. The IOM committee unequivocally and scientifically established that Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome is a physiological, not psychological, illness. The IOM stated firmly that Myalgic Encephalomyelitis/Chronic Fatigue Syndrome is “a serious, chronic, complex, multisystem disease... In its most severe form, this disease can consume the lives of those whom it afflicts.”

The IOM committee further established that between 836,000 and 2.5 million Americans suffer from this devastating disease, which carries with it an economic burden of $17 to $24 billion to our country annually.

I am one of those Americans who has had their life and livelihood stolen by this illness, which renders 25 percent of us house- or bed-bound at some point. While the vast majority of us are not well enough to march on Capitol Hill to demand equitable funding from our government, rest assured we are still able to vote.

As a member of the Senate Subcommittee, I urge you to reinstate this $5.4 million CDC funding immediately. You have an opportunity to be on the right side of history.

Email address
USPS address

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