HUNTER-HOPKINS |
CENTER |
Hunter-Hopkins ME-letter
December 2009
Hunter-Hopkins Center, P.A.
7421 Carmel Executive Park Drive, Suite 320
Charlotte, North Carolina 28226
Tel. (704) 543 9692 á Fax. (704) 543 8547
Contents
Dr. Black Addresses the CFS Advisory Committee
Ampligen Update
XMRV Update
Best Wishes ·
* * *
On October 29-30 Dr. Black represented Hunter-Hopkins at the CFS Advisory Committee hearings in Washington DC. The CFSAC is charged with making recommendations and advice to the Department of Health and Human Services (DHHS) regarding CFS. The CFIDS Association and many private individuals made pleas to the committee to demand a change in the CDCâs handling of research in CFS. The meeting recognized that the senior command at the CDC has not changed in over 20 years and that proposed research programs once again do not address diagnosis, markers of the illness, or treatment.
Dr. Black addressed several poignant issues to the group, including:
á CDC has little to show for 25 years of work and millions of taxpayer dollars
á Diagnostic criteria need to be more specific and objective, and include physiologic biomarkers fter
á After 25years, we still do not have a single specific medical therapy approved by the
á Healthcare providers, scientists and communities must be educated about CFS/ME
á The ongoing mistreatment of patients, and the current lack of appropriate, even adequate, healthcare is an embarrassment to the medical profession.
She went on to call for a change of leadership at the CDC, and support of the CFS Advisory Committee recommendations to DHHS Secretary Sebelius.
Dr. Blackâs testimony can be read by clicking here, or go to http://videocast.nih.gov/Summary.asp?File=15409 for the video and scroll to about 9:42 AM (or 42:00).
The CFSAC has significant concerns about the CDC's five-year plan. In particular, the priorities articulated in its recommendation of May 2009 have not been adequately captured in the latest CDC draft. The CFSAC renews its recommendation that CDC prioritize: identification of biomarkers and (viral) etiology of CFS; partnership with organizations representing CFS scientific expertise to create guidelines for adult and pediatric management; provide web based guidelines for CFS management given our current state of knowledge and expert opinion; and provide comprehensive information about CFS in partnership with CFS experts to the scientific community, medical and mental health providers, educational institutions and the public for both adult and pediatric CFS through DHHS resources. CDC's continued use of the inadequate
and inappropriate 2005 "empiric" research definition for CFS. It recommends that CDC abandon the empiric case definition and the fundamentally incorrect conceptualization of chronic unwellness as being equivalent to CFS incorrect.
Write to Secretary of Health Kathleen Sebelius and elected officials to request action on the CFS Advisory
Committee's latest set of recommendations and the urgency of expanded research. Seretary Sebelius can be contacted via www.capwiz.com/cfids/home .
On December 1, 2009, the FDA responded to Hemispherxâs New Drug Application for Ampligen in a ãComplete Response Letter.ä Many saw this as the FDAâs rejection of Ampligen for the treatment of CFS/ME. To settle the issue, Dr. Lapp flew to Hemispherx headquarters in Philadelphia on December 3 to speak directly with Hemispherx CEO, Dr. William Carter, and medical director, Dr. David Strayer.
Carter and Strayer were actually in good spirits about the FDA letter. Essentially the FDA can respond to an application by approving a drug, rejecting a drug, or by providing recommendations for improving the application, which implies that the drug is ultimately approvable. The Complete Response Letter suggested that Hemispherx perform one more study and clear up some questions about drug safety, specifically effects on immune activation and carcinogenicity. Carter, Strayer, and senior members in the company all indicated that Hemispherx wants to pursue the approval and has the wherewithal to do that.
Hemispherx representatives will meet with the FDA soon to finalize future plans, but it is expected that a study of Ampligen in about 300 patients will commence in the near future.
In the meantime, Dr. Lapp at Hunter-Hopkins Center and Dr. Peterson at Sierra Internal Medicine (Nevada) will continue to offer the compassionate care program at their offices. Currently Ampligen is available only at these sites as part of an experimental protocol. Both groups are seeking to add new subjects to this cost recovery program, called AMP-511. Interested individuals should check out our website ( click here) and then contact Wendy Fallick, our Research Coordinator.
While in Washington to attend the CFS Advisory Committee meeting, Dr. Black met with Dr. Dan Peterson of the Whittemore-Peterson Institute in Reno, NV, to get updated information on the XMR Virus. To date, one of the best summaries of XMRV has appeared in Cort Johnsonâs blog, ãXMRV in the Spotlight.ä You can read this at http://aboutmecfs.org/blog/?p=1048 .
We plan to follow XMRV developments closely, and to participate in ongoing studies. Hunter-Hopkins has already been asked by the Department of Health and Human Services to participate with the Centers for Disease Control and the National Institutes of Health in a prospective study of XMRV in persons with CFS (PWCs). This ãWorking Groupä plans to accomplish three goals: (1) validate and standardize testing for XMRV, (2) confirm the prevalence of XMRV in the general population, and (3) identify modes of transmission. We hope to soon be enrolling patients and controls in a study that will help answer these questions. Recruitment has not yet begun, but please ãstay tunedä! We will inform you when the study begins by way of the ME-Letter and/or our website.
In the meantime, You will be pleased to hear that XMRV studies are beginning in at least 4 US universities, at two British sites, in Sweden and probably Japan. Several private studies have also been initiated.
Merry Christmas and Happy New Year from the doctors and staff at Hunter-Hopkins!
We think of each of you as personal friends, and we sincerely hope that your Christmas will be
filled with joy and that the New Year will bring better health and happiness !
Dr. Lapp, Pam Roper (reception), Rhonda Hill (medical assistant),
Darie Lapp (business office),Danielle Ewalt (administrator),
Wendy Fallick (research coordinator), Kristen (infusionist), Dr. Black
This newsletter is published periodically by Hunter-Hopkins Center, P.A., 7421 Carmel Executive Park, Charlotte, North Carolina 28226, USA..
Telephone (704) 543 9692, Fax (704) 543 8547.
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