CFSAC Testimony: Kim McCleary

Policy Matters | 08. Nov, 2011 by | 11 Comments

Comments to the DHHS CFS Advisory Committee
Public Testimony: November 8, 2011
Kim McCleary

CFSAC-meeting1-300x114Two years ago when this committee met in October 2009, the session held in the Great Hall of the Humphrey Building had star power. The main attraction – XMRV. Called there to speak: retrovirology expert John Coffin; pioneering CFS experts Daniel Peterson and David Bell; and DHHS blood safety expert Jerry Holmberg. Testimony from patients and their advocates pleaded for you to investigate the finding published in Science magazine just days earlier.

You did.

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NIH Clinical Center

DHHS mobilized resources across its agencies – the National Institutes of Health, the Centers for Disease Control and Prevention, the Food and Drug Administration. The blood safety community was rapidly engaged in these efforts through two, then three task forces.  The Blood XMRV Scientific Research Working Group commenced a four-phase multi-lab study to evaluate testing methods and measure the threat that XMRV posed to the blood supply. Several intramural programs within the National Cancer Institute, the CDC’s retrovirology group and at the FDA developed testing methods to look for XMRV and close cousins. When publications from CDC and FDA/NIH groups were at odds, the National Institute of Allergy and Infectious Diseases (NIAID) recruited renowned virus hunter Ian Lipkin of Columbia University to design and coordinate a multicenter study that would draw patient samples from expert physicians’ practices across the U.S. and utilize the various labs’ own tests to look for evidence of this family of retroviruses. The NIH Clinical Center recruited a new cohort of CFS patients, and completed detailed work-ups in the nation’s largest research hospital facility. The FDA’s Blood Products Advisory Committee dedicated substantial segments of two meetings to hear from various experts about the risk to the public posed by these agents. The Red Cross and America’s Blood Centers instituted new policies to educate every potential donor – millions of people – about CFS and to defer any potential donor with a past or present history of CFS. Other countries applied similar policies.

That’s what action looks like.

Now, with more than 20 studies that have failed to confirm that initial finding, new information about the recombinant origin of XMRV and recognition that it is a common laboratory contaminant, it appears the specific threat that sounded the alarm bells has mostly passed. The agencies’ emergency management systems got through the drill. Thank you.

But guess what?

CFS is still here. CFS is still wreaking damage on the lives of at least one million Americans and millions more around the globe. CFS still presents a threat, because we don’t know who will get it or why. We can’t easily diagnose it and treatment is still a patchwork of relatively unsatisfactory symptomatic band-aids.

So, out of the small country of Norway, on Oct. 19, 2011 (again, just days before this meeting), comes news about a small phase II study of Rituxan that showed tremendous promise for 67 percent of the patients who received two doses of this monoclonal antibody used to treat certain cancers and rheumatoid arthritis. Now, the hunt is on for better clues as to why this therapy worked and how to make it better through follow-up studies. But right now, that hunt is only going on in Norway.

I see tremendous opportunity to leverage many of the resources that were assembled to address XMRV. A well-characterized CFS cohort already identified by physicians at the NIH Clinical Center, where there is tremendous experience with the use of monoclonal antibody therapies. The NIH Undiagnosed Diseases Program reported a few weeks ago that in its first two years of operation, one of the most common diagnoses it made was CFS – another source of patients for study. The NIAID has invested in a multicenter network to collect samples for the Lipkin study and the CDC has just let a contract to a collaborative of CFS expert physicians who will meet later this month. This could be the beginning infrastructure to support a long-needed clinical trials group that could be activated to pursue findings such as the one from Norway.

Science-photo1I hope that I leave this meeting with a stronger sense that the emergency alert system that responded so effectively to XMRV will not go dormant. The main attraction that draws us here today – CFS – is still here. We need YOU to mobilize as urgently as did two years ago to disarm it.

K. Kimberly McCleary has served as the Solve ME/CFS Initiative’s chief staff executive since 1991.

November 8, 2011