ME/CFS Primer/Education Newsletters NewsLetter Documents 2009 IACFS/ME Board Members' Submissions to CFS Advisory Committee Meeting

Fred Friedberg, PhD
President
IACFS/ME


As president of the IACFS/ME, I thank the CFS Advisory Committee for this opportunity to present testimony on behalf of my organization.   Six months ago the three major CFS scientific advocacy groups, the IACFS, the CFIDS Association of America, and this committee all recommended new, open-minded leadership at the CFS research program in the Centers for Disease Control.  We commend this bold and important action by the CFSAC.

Despite this unprecedented consensus, the CDC has shown no indication of changing its CFS program leadership. This is surprising given its track record to date.   After 25 years (and over $100 million) of CDC research, chronic fatigue syndrome remains a stigmatized illness without substantive progress on public health policy or objective diagnosis and treatment. And their new 5 year $25 million plan fails to inspire any confidence that change will occur. 

In fact, the consensus recommendation of these scientific advocacy groups was based on dissatisfaction with the CDC’s ill-conceived and impossibly far-reaching 5 year research plan. 

President Obama said in his inaugural address: The fundamental question of our time, is not whether government is too big or too small, it will be whether it works.  The CDC is the world public health authority; It can certainly provide more effective leadership in this poorly understood domain.

I am speaking not only for my organization but for several prominent biomedical scientists whose opinions should be considered in our ongoing efforts to effect change. These individuals were unable to speak today.
Gudrun Lange was a member of the distinguished external review panel that in 2008 evaluated the CFS program at CDC; She asked me to read this quote:

“I am very disappointed that CDC has not been more proactive in implementing important suggestions made by peer reviewers. The committee recommended that CDC, as the lead health agency dealing with CFS, establish closer relationships with other traditional public health agencies to further promote CFS as a significant health concern.  This includes using public service announcements to alert the public about CFS as an important health issue.  In addition, it is rather surprising that CDC has not shown any initiative to address obvious research questions posed by the H1N1 epidemic.  Why are we not surveilling the population for post-infectious fatigue following H1N1?”

Distinguished UK scientist and geneticist, Jonathan Kerr, expressed the following:

Research output on CFS from the CDC in the last 5 years has been principally in the areas of gene expression and mutation.  These studies used patients who did not attend CFS clinics and were not diagnosed by recognised CFS clinicians. A microarray was utilised which did not represent the entire human genome (yet such an array was available at the time). But, at no time were the microarray gene profiles confirmed using real-time PCR, a standard procedure in microarray studies because the arrays are very sensitive but not very specific. The findings of these papers do not lead anywhere and were not followed up by CDC. They do not provide insights into pathogenesis, nor do they indicate candidate treatment targets. The authors made no effort to explain their work in context of the available CFS gene expression literature.

Recommendations

Although the CDC program has ignored the views of scientific advocacy groups, their CFS program will not go forward without challenge.  Nor will this widely supported protest be confined to one meeting of this committee. We ask the CFSAC to support us in our ongoing efforts. We respectfully recommend the following:
  • A continuing critical focus on the CDC chronic fatigue program during this and subsequent meetings until the leadership is changed.
     
  • A new scientific forum at the CFSAC that allows biomedical scientists who wish to speak at the meeting the opportunity to do so.  This is important because prominent scientists and clinicians who attempted to register to speak 3 weeks in advance of this meeting were wait-listed.
     
  • Permission for non-US biomedical experts in CFS to participate in these scientific forums. They are not permitted to speak now. Given that there are so few CFS experts worldwide, we need informed views to make informed recommendations.
If we the CFS scientific community remain united in common purpose we can lead the way to major new public policy initiatives and research programs that advance the recognition and understanding of this still poorly understood illness.
Thank you.

Public Comment of Lee Meisel
CFSAC Meeting (October 30, 2009)

I am a physician and attorney with 20 years of experience in the biotechnology and specialty chemical industries.  I have also been a CFS patient for the last 20 years.  I am currently a director of both the IACFS/ME and Epiphany Biosciences and have previously served as a director of other biotechnology and not-for-profit companies, including the HHV-6 Foundation.

This illness is at a critical juncture in its history both in terms of (i) major research findings that have the potential to transform the lives of millions, and (ii) the politics that could allow ground breaking research to blossom and flourish into game changing research.

Two studies reported over the last couple of months have brought us to this threshold:

1.     The publication this month in Science of the detection of XMRV (xenotropic murine retrovirus) in CFS patients is a landmark study.

2.     The presentation last month of the valomaciclovir trial at the ICAAC Conference (Interscience Conference on Antimicrobial Agents and Chemotherapy) marks the first in vivo demonstration of an anti-EBV effect of a drug in a phase 2, FDA-approved clinical trial.

In the valomaciclovir trial, the median EBV viral load in the saliva of patients treated with valomaciclovir was undetectable at the end of the treatment period and reached statistical significance with a p value of 0.002.  Clinical course of illness was also significantly improved in the valomaciclovir group with a p value of less than 0.05.

The potential implications on EBV infectivity in infectious mono are obvious. With approximately 9-19% of patients progressing to meet criteria for CFS (Isaacs 1948; White et al 1998; Buchwald et al 2000; Hickie et al 2006; and Katz et al 2009), the design for the next valomaciclovir trial will include an assessment for incidence of CFS at 6 months post-symptom onset.

With sufficient levels of funding from public and private sources to pursue a comprehensive natural history trial in infectious mono, the next valomaciclovir trial would be able to include assays of XMRV, other viruses of interest and promising CFS biomarkers to gain a complete understanding of the early phases of CFS for the very first time.

Twenty-five years after the Lake Tahoe epidemic, we have finally built the foundation for CFS research to literally explode with innovative new findings, but for the absence of a productive research program at CDC and ample, dedicated research funding allocations from NIH.

The CDC’s Five Year CFS Strategic Plan and the levels of CFS research funding at NIH are not just woefully inadequate.  They are an embarrassment.  But this wouldn’t have to be the case if political will was exercised to make the necessary organizational and cultural changes at CDC and NIAID (National Institute for Allergy and Infectious Disease).  One of the most glaring deficiencies of past CDC stewardship has been the failure of the CDC to develop extensive collaborative relationships with extramural researchers.  Worse yet, NIAID’s research plan for CFS is virtually non-existent.  A CFS research program housed in the Office of Women’s Health is not a substitute for a robust CFS research program headquartered in NIAID. 

The ideal clinical trial as described above that studies that natural history of infectious mono as it morphs into CFS would be the perfect opportunity for the CDC and NIH to develop an intensive, interventional, natural history study that would be truly transformative.  Unfortunately, the leadership of the CDC and NIH when it comes to CFS is neither visionary, nor have they prioritized CFS research.

Mike Houghton, discoverer of hepatitis C, Lasker Award winner and Chief Scientific Officer of Epiphany Biosciences, recently asked me three questions:
  1. Why don’t CDC and NIH have programs that diagnose and monitor CFS patients to establish the characteristics of CFS in patients with an onset consistent with an acute infection? 
  2. Why aren’t all available pathogen signature tests used by the CDC and NIH in this population to establish the infectious etiology?
  3. Why hasn’t the CDC and NIH monitored the virological and host signature status of at risk patients and compared the patients who resolve their infection to those who do not? 
I had no answers for Mike to any one of these questions, except to say that a private foundation, the Whittemore Peterson Institute, has been working very hard to try to address your questions.  This type of research program has been ongoing for many years for hepatitis C and HIV/AIDS and now needs to be applied to CFS in an expansive and systematic manner.  Such a program requires tremendous resources and technical expertise.  CFS patients deserve the same degree of scientific rigor that has been applied to the study of hepatitis C and HIV/AIDS. 

This is our moral imperative.  A Congressional investigation is long overdue to explore potential allegations of malfeasance or intentional misconduct at CDC and to explain why the CDC who has been continuously working on CFS research over the last 25 years has been unable to uncover what a private foundation spending less than $2 million has been able to discover in two years.

The CFS leadership at the CDC and NIH has alienated a great number of CFS stakeholders.  Let us seize this moment in history as it presents itself to us.  The fruit on the vine could not be any riper.  It is time for our government to finally do the right thing and serve its constituents, instead of itself.  It is time for the CDC and NIH CFS research programs to be re-built from scratch, from the ground floor, with a new culture and with new leadership.
Lee Meisel, M.D., J.D., M.P.H.


Public Testimony of Staci Stevens for CFSAC Meeting Oct. 29th, 2009

Dear CFSAC Members:

I would like to express my gratitude to those serving on the CFSAC, now and in the past, who have given of their time and expertise. Despite your good work, there has not been a written response from DHHS to a single recommendation of this committee since 2003. This is unacceptable and must be changed. That said, I give credit to those ex officio members who have acted courageously in moving forward with recommendations from the CSFAC. For those of you who have done so, I thank you.

CFS is a physical disease, and we can identify, characterize, and measure its most distinctive and disabling features. The gold standard in medicine is to identify and employ objective measures to evaluate disease and illness severity. That is what we do at the Pacific Fatigue Laboratory; evaluate multisystem function and impairment in CFS. A medically determinable impairment requires objective evidence. For example, we have developed an objective serial cardiopulmonary exercise test protocol using AMA guidelines that measures functional impairment as well as the metabolic, cardiovascular and pulmonary systems both at rest and during exercise. The protocol elicits and measures both fatigue and post-exertional malaise, considered to be a hallmark symptom of CFS.

By contrast, the CDC recommends the use of self-report questionnaires to diagnose and quantify this illness. Questionnaires simply do not provide the evidence required by the Social Security Administration or long term disability carriers to diagnose medical illness or to determine a disability claim. That questionnaires have become the standard of diagnosis for CFS at the CDC shows how little progress they have made in the last 25 years in characterizing this disabling syndrome. 

The questionnaire approach to diagnosis in CFS at the CDC has also been criticized by psychiatrist Eleanor Stein, the IACFS Ambassador from Canada. As she was unable to speak today, she asked me to read the following statement,

“I would like to express my strong concern about the harm being done by using the 2005 empiric definition of CFS. This definition recommends diagnosing CFS using 3 self-report questionnaires: 2 of the 3 are non specific and erroneously include people with a wide variety of disorders including primary psychiatric problems. It is obvious to me as a dedicated CFS clinician that I cannot use the Empiric Definition in good faith in my practice; I rely on the Fukuda and the Canadian Consensus definitions for diagnosis and all medical-legal issues. The Empiric Definition has resulted in a dramatically increased prevalence in CFS in the US.  Studies by Jason et al have shown that this increased prevalence may be due to the inclusion of persons with depression.

Without a sensitive and specific case definition, how can future research hope to uncover the biomedical underpinnings of this disorder for the benefit of those who suffer?  It is my hope that the CFSAC will make a public statement that the Empiric Criteria should not be used for either clinical care or research and that until a better definition is created the Fukuda and/or Canadian Consensus Definitions should be used.”

Given the lack of progress at CDC, the CFS Advisory Committee’s number one recommendation from their last meeting was to, “establish new leadership at the CDC for the CFS program.” This recommendation was in concert with those made by the IACFS/ME and CFIDS Association of America. Yet, this unified call for change from the three most respected organizations in the field has gone unheeded. We have objective measures. We have discernable physical characteristics.  It is well past time for the CDC to become responsive to the researchers, clinicians and patients who are united in their insistence on objective diagnostic criteria rather than self-report questionnaires to characterize this disabling illness.

Respectfully,

Staci R. Stevens, MA

Founding Executive Director
Pacific Fatigue Laboratory, University of the Pacific
IACFS/ME Board Member, Secretary

Back to IACFS/ME Newsletter, December 2009