Take Five with Kim McCleary
Our CEO answers five questions that have been a source of concern
When you were interviewed by CNN and NPR about the PACE study, why didn’t you criticize the use of the Oxford definition or the many other weaknesses?
Both those interviews were longer and more detailed than the selected quotes in the final stories suggest. In both, I immediately raised the case definition, selection of less severely ill and more recently ill subjects, and weaknesses that were detailed in my commentary, “Too Big to Fail,” and our analysis of the study, “Falling Off the PACE.” However, reporters were sent the Lancet’s press release, a recording of the Lancet’s press conference and a press release from the U.K. Science Media Centre –a well-orchestrated media campaign. The two reporters with whom I spoke were loaded with reasons why the Oxford definition didn't matter, post-exertional relapse was accounted for, and they dismissed all the reasons I stated that the study – and swift conclusions – were flawed. It was clear they had the story they wanted and that I was being interviewed strictly to suggest editorial balance. I found it curious that both reporters asked whether the patient community would object as strenuously if a study of antivirals had the same flaws yet showed some promise for even a subgroup of patients. That added to my feeling that the interviews had been set up. I didn’t consent to other interviews after these two. I regret that I wasn’t able to convince them of the study’s major limitations.
Did you tell the CNN reporter that you thought the services provided in the PACE study should be made available in America?
As we addressed in “Falling Off the Pace” and “Too Big to Fail,” all the participants in the PACE trial received three sessions of specialized medical care in the six-month study period. The professionals who delivered the medical care and the behavioral therapies were prepared to deliver these services for the study through extensive training sessions and hundreds of pages of careful scripting. They were taught to support the patient and validate their past and present experiences. Yet, in the real-world U.S. health care marketplace, it is exceedingly rare for CFS patients to find supportive professionals who are educated about CFS and understand the severe physical limitations it imposes. The point I made when talking with the CNN reporter was that it was impossible to compare the carefully crafted services in the PACE trial to what American CFS patients might encounter if they are referred for CBT and GET. It was therefore inappropriate to translate the results of the PACE trial into a directive to patients that talk and exercise would help.
Can you explain your statement about resisting a blood ban?
This is the April 9, 2010 quote that has received so much attention:
“I’ve noted online that several European CFS/ME patient organizations are preparing to petition their governments to follow Health Canada’s lead. So far we are resisting pressures to do likewise, with expectation of a report on the blood safety study to come, hopefully in time for the May 10  DHHS CFS Advisory Committee meeting.”
This statement was part of a longer e-mail sent to members of the AABB Interorganizational XMRV Task Force of which I am a member. All AABB committees and task forces are subject to strict confidentiality policies and we are reminded at the beginning of every conference call and frequently by e-mail that discussion and correspondence is subject to that policy. That policy limits what I can say about the discussions of which this e-mail was part.
In early 2010, other countries (Canada, New Zealand, Australia) were announcing blood bans for CFS, but they were not doing anything else to operationalize the policy. Blood centers in those countries do not ask blood donors about CFS/ME diagnosis/history, nor do they include any material about CFS/ME in the donor education resources to inform them that people with CFS should not donate blood.
Many individuals in the U.S. CFS community were calling for the same kind of ban. Within the AABB Task Force, we were having an extended discussion about how to take action that would be a more effective blood safety measure than other countries’ somewhat cosmetic policy. Within a few weeks of that e-mail, on June 18, 2010, the AABB issued its guidance. It was implemented immediately by Red Cross and America's Blood Centers and was fully effective as of Oct. 1. In December 2010, when the FDA’s Blood Products Advisory Committee (BPAC) asked for input on whether to formally defer CFS patients from giving blood, the Association gave testimony that it should permanently defer CFS patients from donating blood. (The term “ban” is not customarily used in U.S. blood donation policies.) FDA is still considering that issue with the input from the BPAC and other organizations.
Will the CFIDS Association send a letter to authorities about the proposed change in the ICD-10CM to coding for CFS?
We have attempted to engage on ICD coding issue since the late 1990s when the ICD-9 revisions were being made. It is a fine-grained policy process conducted under the nearly independent authority of a narrowly focused but highly experienced government bureaucrat within the National Center for Health Statistics. It is extremely unlikely that any changes to the proposal will be made without substantial evidence about the impact of coding changes on the reimbursement and payment processes followed by various state-regulated insurance companies. We simply do not have access to such data, nor do we have the ability to generate it. (The Association has no ties – financial or otherwise – to any insurance company.) If there is an opportunity to express support for coding CFS in a manner that maximizes reimbursement for services and testing, we will do so.
Does the CFIDS Association endorse the use of the Oxford or empiric definitions for CFS research?
No. Our requests for applications for research and our SolveCFS BioBank both utilize the 1994 Fukuda definition (as a minimum) and recognize the more stringent Canadian clinical definition. The Canadian clinical definition was not written for research purposes, and therefore more work needs to be done to operationalize terms to facilitate comparability across research centers. The Association believes that the case definition for CFS must be revisited so that patients are selected according to criteria that improve chances for identifying biomarkers. The impact of case definitions that are too broad has been raised in the New York Times and the Wall Street Journal and we have been having discussions with various public agency officials about the need to address this topic to improve research outcomes.
For answers to more frequently asked questions about the Association, please visit our FAQs.
March 14, 2011
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