LYMEPOLICYWONK: Diane Blanchard’s Comments to IOM Committee
My name is Diane Blanchard. By way of introduction, I am co-founder and co-president of Time for Lyme, based in Greenwich, CT. Through years of experience, as a mother of sick children, advocate, research funder and supporter, I know the field of Lyme disease. I sit on the board of the only Research institution in the United States devoted to the study of Lyme and Tick-borne Diseases — at Columbia University – and I have directed funding through TFL to such research areas as sequencing the genome of multiple strains of B burgdorferi, developing protein arrays of large parts of the proteome in search of new antigens for diagnostic tests, biomarker research of both the serum and cerebrospinal fluid, studies on the immunopathogenesis of Lyme disease and developing new techniques for the identification of other pathogens in ticks which may be causing co-infections with Borrelia burgdoreri.
I am honored to play the role of an advocate for this disease. Lest you attempt to separate advocacy from the state of the science – I would like to point out that it was another advocate, Polly Murray who in Lyme Connecticut, recognized this new disease and the havoc it was causing in children. She did the initial informal epidemiology and brought it to the attention of Dr. Allen Steere, the rest is history.
During those early days when the etiology of Lyme disease was not known, careful attention was paid to patient’s symptomatolgy and paradigms were formed to explain it. When the Lyme disease organism was discovered, there was a change from this patient centered approach of trying to understand Lyme disease from symptom complex to trying to pigeon-hole Lyme disease into a box consistent with crude, non-specific and insensitive diagnostic techniques. The crude nature of the diagnostic techniques and the difficulty in cultivating the organism is recognized almost universally.
That is the history. And it has continued to dog the present – Lyme cannot and will not fit into a box. Everywhere you look you see evidence of that, and of a disease whose progression is no better understood now than it was then. What I know more than anything from my experience is that we have failed to characterize this disease, its diagnosis and its treatment. This panel needs to take note, it is not about whether a research study was performed properly and thereby gives a very limited and myopic view, it is about the fact that a significant number of patients continue to suffer after their first attack of Lyme disease. It is the fact that we are failing our patients.
Why: Because the current diagnosis and treatment for Lyme disease relies on circular reasoning and sophistry–this highly vocal bias has suppressed the development of new science and technology for this disease. It has allowed research that is out of date, reliant on small sample size and selective criteria to prevail.
It is my goal here today to address this issue of bias which is holding us back so severely.
A stated guideline in the IOM Study Guide says “A point of view or bias is not necessarily a conflict of interest.” Unfortunately, bias is a huge issue in Lyme and has controlled much of the research we have, which has been driven by the viewpoints of a handful of individuals who receive the lion’s share of NIH grants. The science has been politicized, relatively little resources are directed toward understanding the full compendium of disease manifestations, diagnosis and treatment. Lyme disease has been relegated to the position of not being a significant clinical problem. The official IDSA website says in effect, if your symptoms infection does not resolve after treatment, you do not have Lyme disease. 100% efficacy of treatment, this is a first in infectious diseases. Instead, research has been directed largely to understanding Borrelia burgdorferi as a paradigm of spirochetal biology.
This bias has stunted patient care because clinicians lack research to guide them. Bias has ruined the state of this research and had a serious ripple effect on diagnostics and treatments – no patient care, no comparative studies, no doctor development and no understanding of the disease progression. Current established thinking is largely based on IDSA opinion-based evidence. It appears that the state of the science has become a matter of “belief” and it is this belief that has given rise to restrictive research and guidelines for treatment that would seem to “prove” their theory. The stated disbelief in chronic Lyme runs completely contrary to the early epidemiologic studies demonstrating that 5- 10% of treated and untreated patients go on to develop a multisymptom disorder. Furthermore, results of animal and human treatment studies appear to support the hypothesis that persistent infection occurs and may be responsible for the chronic symptoms.
This panel needs to be aware of bias among themselves as well as the bias of presenters and that of researchers whose studies are evaluated. You are all professionals, eminent scientists and physicians. You will give great weight to what your fellow professionals will say. But please remember, in the United States, Lyme disease was initially discovered by a mom taking care of her kids and neighbors. Please listen to the patients, they have the most to gain and lose from this proceeding. If bias is not balanced, the outcome of this conference will lack both scientific integrity and moral force needed, and the progress of science will continue to be impeded.
