Dr. Meisel webcast URL - http://www.youtube.com/watch?v=3D8NMhksB68zw=20
Public Comment of Lee Meisel
CFSAC Meeting (October 30, 2009)
I am a physician and attorney with 20 years of experience in the biotechn=
ology 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 an=
d Epiphany Biosciences and have previously served as a director of other =
biotechnology and not-for-profit companies, including the HHV-6 Foundatio=
n.
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 resea=
rch to blossom and flourish into game changing research.
Two studies reported over the last couple of months have brought us to th=
is threshold:
1. The publication this month in Science of the detection of XMRV (xenotr=
opic murine retrovirus) in CFS patients is a landmark study.
2. The presentation last month of the valomaciclovir trial at the ICAAC C=
onference (Interscience Conference on Antimicrobial Agents and Chemothera=
py) 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 p=
atients treated with valomaciclovir was undetectable at the end of the tr=
eatment period and reached statistical significance with a p value of 0.0=
02. Clinical course of illness was also significantly improved in the va=
lomaciclovir group with a p value of less than 0.05.
The potential implications on EBV infectivity in infectious mono are obvi=
ous. With approximately 9-19% of patients progressing to meet criteria f=
or 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 purs=
ue a comprehensive natural history trial in infectious mono, the next val=
omaciclovir 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 th=
e foundation for CFS research to literally explode with innovative new fi=
ndings, but for the absence of a productive research program at CDC and a=
mple, dedicated research funding allocations from NIH.
The CDC=E2=80=99s Five Year CFS Strategic Plan and the levels of CFS rese=
arch funding at NIH are not just woefully inadequate. They are an embarr=
assment. But this wouldn=E2=80=99t 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 t=
he failure of the CDC to develop extensive collaborative relationships wi=
th extramural researchers. Worse yet, NIAID=E2=80=99s research plan for =
CFS is virtually non-existent. A CFS research program housed in the Offi=
ce of Women=E2=80=99s Health is not a substitute for a robust CFS researc=
h program headquartered in NIAID. =20
The ideal clinical trial as described above that studies that natural his=
tory of infectious mono as it morphs into CFS would be the perfect opport=
unity for the CDC and NIH to develop an intensive, interventional, natura=
l history study that would be truly transformative. Unfortunately, the l=
eadership of the CDC and NIH when it comes to CFS is neither visionary, n=
or have they prioritized CFS research.
=20
Mike Houghton, discoverer of hepatitis C, Lasker Award winner and Chief S=
cientific Officer of Epiphany Biosciences, recently asked me three questi=
ons:
1. Why don=E2=80=99t 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? =20
2. Why aren=E2=80=99t all available pathogen signature tests used by the =
CDC and NIH in this population to establish the infectious etiology?
3. Why hasn=E2=80=99t the CDC and NIH monitored the virological and host =
signature status of at risk patients and compared the patients who resolv=
e their infection to those who do not? =20
I had no answers for Mike to any one of these questions, except to say th=
at a private foundation, the Whittemore Peterson Institute, has been work=
ing very hard to try to address your questions. This type of research pr=
ogram has been ongoing for many years for hepatitis C and HIV/AIDS and no=
w needs to be applied to CFS in an expansive and systematic manner. Such=
a program requires tremendous resources and technical expertise. CFS pa=
tients deserve the same degree of scientific rigor that has been applied =
to the study of hepatitis C and HIV/AIDS. =20
This is our moral imperative. A Congressional investigation is long over=
due to explore potential allegations of malfeasance or intentional miscon=
duct 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 discove=
r in two years.
=20
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 ou=
r government to finally do the right thing and serve its constituents, in=
stead 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.
=2E
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