2013 - A Year to Remember

Bob Miller skydiving for ME on May 12

By Erica Verrillo

What a year this has been for the ME/CFS community!

With four major conferences held in the US, the UK, and Australia, the inauguration of two new research and treatment centers, the first FDA meeting to discuss drug development for ME/CFS, fireworks at the CFSAC, the still unabated IOM controversy, an unprecedented consensus from the top 50 ME/CFS experts, two exciting new documentary projects, and an upsurge in advocacy efforts, this has been a year to remember.

Meetings: FDA Developments and Fireworks at CFSAC

The FDA held its first ever ME/CFS workshop, Drug Development for Myalgic Encephalomyelitis Chronic Fatigue Syndrome (ME and CFS), April 26 and 27, 2013 in Washington, D.C. The first day of the meeting was titled “Disease Symptoms and Daily Impacts That Matter Most to Patients” and featured presentations by patients, including Dr. Jon Kaiser, Joseph Landson, Charlotte Von Salis, Tasha Kelemen, Matina Nicholson, Mary Schweitzer, Mindy Kitei, and many others. Patient advocates Mary Dimmock, Dr. Janet Smith and Denise Lopez-Majano also described how the illness has affected their family and friends. ME/CFS physicians and researchers Dr. James Baraniuk, Dr. Charles Lapp, Dr. Steven Lempert, Dr. Judy Mikovits, Dr. Derek Enlander and Dr. Dan Peterson addressed the necessity of developing treatments, even if the cause remains unidentified. (You can read about the first day of the FDA workshop HERE.)

The second day of the FDA development workshop for ME/CFS focused on clinical trial design, outcome measures, regulatory issues and possible pathways to expedite drug development for CFS and ME, as well as the development of clinical trials. (You can read about the second day of the FDA workshop HERE and HERE.)

The May 22-23 CFS Advisory Committee (CFSAC) meeting was held, as usual, in

Eileen Holderman

Washington, D.C. The meeting, which was streamed live, was chaired by Gailen Marshall, and attended by Wanda Jones, former chair of the committee, Kim McCleary, CEO of the CFIDS Association of America, Fred Friedberg, president of the International Association of CFS, Ken Friedman, representing the New Jersey CFS Association, Ermias Belay of the CDC, Susan Maier of the NIH, Theresa Michele of the FDA, Mary Ann Fletcher, Dane Cook, Steve Krafchick, and Eileen Holderman, among others. While the first day revolved around ongoing government projects, such as the CDC’s multi-site study, the second day of the meeting produced fireworks when voting member Eileen Holderman accused the Designated Federal Officer, Nancy Lee, of intimidation. The negative publicity generated by Ms. Holderman’s (and Ms. Mary Ann Fletcher’s) contention that they had been bullied and threatened with expulsion for stating their views ultimately led to the demotion of the fall CFSAC meeting to a webinar.

Conferences at Home and Abroad

On January 26, The Institute for Neuro Immune Medicine hosted a patient conference about Gulf War

Nancy Klimas (center) and staff

Illness and ME/CFS in the DeSantis Center at Nova Southeastern University. Speakers included Dan Peterson, MD; Gordon Broderick, PhD; Mady Hornig, MD; Connie Sol, MS; Irma Rey, MD; Sue Levine, MD; Nancy Klimas, MD; Dolores Perdomo, PhD; Lynn Rafferty, PharmD; Scott Carlson (Exec. Director Chronic Fatigue Initiative); and Rebecca Halstead (Army Brigadier General, retired). Because this was a patient-centered conference, presentations included new treatments, coping techniques, and stories of recovery. (Videos of the conference can be viewed HERE.)

On May 31st, Invest in ME, a UK charity, held its 8th annual conference to explore biomedical research into ME. This year's conference, titled "Mainstreaming ME Research: Infections, Immunity and Myalgic Encephalomyelitis,” featured a roster of noted physicians and researchers: Dan Peterson and Andreas Kogelnik, who shared the keynote address; Mady Hornig on pathogen discovery in ME; Olav Mella and Oystein Fluge speaking about Rituximab, and more. (For a full program of presentations go HERE. Read Mark Berry's excellent report on this fascinating conference HERE.)

Dr. Derek Enlander

Hemispherx Biopharma, the makers of Ampligen, sponsored a conference at the New York Academy of Medicine on "Diagnosis, Treatments and New Developments in ME and CFS" on November 20th. Speakers included Dr. Nancy Klimas, Institute for Neuro Immune Medicine at Nova Southeastern University; Dr. Daniel Peterson, Sierra Internal Medicine; Dr. Judy Mikovits, Dr. Eric Schadt, Institute for Genomics and MultiScale Biology at Mount Sinai Hospital; and Dr. Derek Enlander. The Q&A panel included Dr. Francis Ruscetti, National Institute of Health and Dr. Christian Becker, Critical Care Medicine in New York. Regrettably, the conference was not filmed.

The 2nd International Symposium for CFS/ME was held on December 2nd, in conjunction with the opening of the National Centre for Neuroimmunology and Emerging Diseases (NCNED) at Griffith University. Hugh Perry (Southampton, UK) gave the inaugural Alison Hunter Memorial Foundation address, including a

Hugh Perry

detailed presentation on the neurological effects of ME titled “Impact of Systemic Inflammation on the Brain.” Presentations included: Elena Gonzalez-Rey (Granada, Spain) –“ Cortistatin – A Possible Future Therapy for Chronic Fatigue Syndrome,” Mario Delgado (Granada, Spain) – “Vasoactive Intestinal Peptide – A Potential Therapy for ME/CFS?,” Gilles Guillemin (Sydney, Australia) – “Tryptophan Metabolism,” Richard Kwiatek (Adelaide, Australia) – “Neuroimaging, Chronic Fatigue Syndrome, Depression and Anxiety: Similarities and Differences,” Sonya Marshall-Gradisnik (Gold Coast, Australia) – “NCNED’s Research Direction,” Ekua Brenu (Gold Coast, Australia) – “Immune System Overview,” Sharni Hardcastle (Gold Coast, Australia) – “Immunological Profile,” Samantha Johnston (Gold Coast, Australia) – “The Definition Question,” Dan Peterson (Simmaron Research Foundation, Nevada, USA) – “Diagnosis and Management,” Kathy Rowe (Melbourne, Australia) – “Prognosis for Adolescents with Chronic Fatigue Syndrome,” Sarah Knight (Melbourne, Australia) – “Children with ME/CFS,” Rosamund Vallings (Auckland, NZ) – “Educating Doctors,” and Warren Tate (Dunedin, NZ) – “Molecular Pathways in ME/CFS.” (You can read Ros Vallings' excellent summary of the conference HERE.)

Advocacy Efforts

Bob Miller

2013 was a very busy year for advocates. The year started with a bang when Bob Miller began a 12-day hunger strike over the FDA’s continued refusal to approve Ampligen, the only ME/CFS pharmaceutical medication that has ever been in clinical trials. Bob, who himself is taking Ampligen, also delivered a petition with 3,890 signatures to the FDA and Secretary of Health seeking Ampligen’s approval. Bob ended his hunger strike on February 10th, after receiving the assurance of Wanda Jones at the Assistant Secretary of Health’s office that Secretary Sebelius would make a serious commitment to address the unmet needs of the ME/CFS community. Ampligen was not approved.

The secret attempt of CSFAC in January to shorten (and alter) the wording of the list of priorities led Jennie Spotila to contact Public Citizen, a watchdog non-profit that has litigated cases under FACA in the past. Public Citizen sent a letter of protest to the Acting General Counsel of HHS on February 14, 2013. The letter points out that the FACAviolations deprived “Ms. Spotila and the public generally of important rights to write a letter calling for an immediate investigation into threats made against three members of the CFS Advisory Committee (CFSAC).

Jennie Spotila

observe and participate in the advisory committee process.” Public Citizen asked that the General Counsel “act to ensure that CFSAC complies with FACA and with its own charter going forward. Despite Jennie’s worthy attempts at setting CFSAC on a straight course, it continued to veer into questionable political territory when, in May, Eileen Holderman and other CFSAC members reported harassment by Nancy Lee, the Designated Federal Officer. This prompted twelve ME/CFS patient organizations and 23 patient advocates to

HHS dealt with the demand for an investigation with characteristic torpor. After more than four months, Assistant Secretary Dr. Howard Koh finally responded to the request for an investigation with the statement that “Dr. Nancy C. Lee has authority to engage in private conversations with individual members of CFSAC.” After finding Dr. Koh’s letter “completely unacceptable,” Mary Dimmock wrote a second letter to HHS demanding an investigation. As of this writing, the matter is still unresolved.

Mary Dimmock

In similar fashion to its highhanded treatment of CFSAC complaints, over Labor Day weekend HHS announced that it would be contracting the IOM to devise a new case definition for CFS. Given the IOM’s previous history of mishandling the definition of Gulf War Illness (relabeled as “Chronic Multi-System Illness"), advocates immediately demanded that the contract be rescinded, as did 50 of the top international experts in the illness. Over 6,000 people signed two petitions calling for the cancellation of the IOM contract and the adoption of the Canadian Consensus Criteria. The experts’ letter marks what can only be called a sea change in the relationship between advocates and clinicians. For the first time, the two groups stood united in their criticism of the way HHS has historically treated the ME/CFS community. They were also united by their goal, the immediate adoption of the Canadian Consensus Criteria. By the end of 2013, the controversy still has not abated, and it promises to extend well into 2014.

At the end of 2013, I am sad to report that Karina Hansen, a 24-year-old severely ill ME patient, is still

Karina Hansen

incarcerated in a psych ward in Hammel Neurocenter in Denmark. On Feb 12th, 2013, five policemen from Holstebro county, Denmark, came to Karina’s house and forcibly removed her from her bed. She was then taken to Hammel Neurocenter, where she is being treated for “psychosomatic illness” with CBT and exercise by psychiatrist Nils Balle Christensen. After almost nine months of daily “rehabilitation,” Karina is still not able to walk. Nils Balle Christensen has declared Karina incompetent in any matters regarding her treatment, and has banned her parents from visiting her. (The case of Justina Pelletier, a 15-year-old with mitochondrial disease who has been confined to a psych ward at Boston Children’s Hospital, bears remarkable similarity to Karina Hansen’s story.) In their most recent public statement, Karina’s parents said that “Karina has become an involuntary guinea pig for psychiatry.”

New Research and Treatment Centers

Nancy Klimas

On February 12th, Nova Southeastern University’s College of Osteopathic Medicine held a grand opening for America’s first Institute for Neuro Immune Medicine. The Institute, directed by Nancy Klimas, is the only one of its kind in the United States that treats patients with CFS/ME and Gulf War Illness (GWI), as well as conducting basic and clinical research under one roof. The Institute is the first in the nation to study neuroinflammatory and neurodegenerative disorders such as CFS/ME, GWI, Parkinson’s Disease and multiple sclerosis using the newest genomic techniques. “We have created a one-of-a-kind think tank that will become the leading neuro immune medicine institute of its kind in the United States,” said Nancy Klimas, M.D. (Read the announcement HERE.)

Griffith University (Australia) opened a new facility, the National

Sonya Marshall-Gradisnik

Centre for Neuroimmunology and Emerging Diseases (NCNED), on December 2nd. The new center, directed by one of the world’s foremost experts on CFS/ME, Professor Sonya Marshall-Gradisnik, is dedicated to researching the interactions between the nervous system and the immune system.  In February 2014 the center plans to open a specialized CFS/ME Clinic. The facility will provide treatment for patients with the illness, and will build on the research being conducted at the center.

New ME/CFS Film Projects

Ryan Prior’s documentary film project, The Blue Ribbon:

Ryan Prior

ME/CFS and the Future of Medicine, garnered over $17,000 on Kickstarter. The idea for the film began with a story Ryan wrote for USA TODAY about his own struggle with ME/CFS over the last 6 years. The response to the article was dramatic, prompting Ryan to embark on a film that would tell the stories of the many people suffering from this illness. To support his film, Ryan launched the Blue Ribbon Foundation, which aims to raise money for the completion and distribution of his film.

Jennifer Brea, winner of ProHealth’s 2013 Advocate of the Year Award, raised an impressive $210,000 for her full-length

Jennifer Brea

documentary, Canary in a Coal Mine. Her project also won Tribeca’s Project of the Month for November. Jennifer contracted ME/CFS while finishing her doctorate at Harvard. Her background in political science and statistics prompted her to investigate the illness, and to question the prevailing attitude in medicine that it is a disease that has no cause, no cure, and no explanation. Jennifer hopes that to convince clinicians and researchers that this is not only a serious illness worthy of their attention, but, in her words, “it’s also a fascinating puzzle.”

Prediction for 2014

2013 was a year we will all remember, because it was marked by rising expectations. The FDA meetings seemed to signal a renewed interest on the part of the federal government to help ME/CFS patients in our quest for effective treatment, as did the acknowledgment that it was a serious and debilitating disease. The building – and dashing – of those expectations has sparked an outpouring of advocacy efforts unprecedented in recent years. Jeannette Burmeister’s call for the approval of Ampligen, citing “unequal treatment” regarding FDA’s rapid approval of Bexsero vaccine for a Princeton students, is another step along the path we will surely continue to take in 2014.

My prediction for 2014 is that it will be the “Year of the Advocate.”  2014 marks the 30-year anniversary of the Incline Village outbreak, the epidemic that saddled us with the name “chronic fatigue syndrome.” It is clear that those who have been ill since the 1980s have run out of patience. Cort Johnson’s recent analysis of HHS’s lack of commitment to people with ME/CFS is a harbinger of things to come. In the following months there will be more protests, more petitions, more demands for funding, and more exposes of government neglect.

What is truly astonishing, is that after 30 years of being blacklisted, after watching our young people with ME thrown into psych wards, after having research funds “redirected,” after the insults, the derision, the blatant dismissal of an illness which has robbed us of our lives – we are still here, still fighting to make our voices heard … still undefeated.

Originally published on ProHealth.