LYMEPOLICYWONK: Diane Blanchard’s Comments to IOM Committee
I am posting the written speeches of those who commented during the public comment period of the IOM. The speech below is that of Diane Blanchard, Co-President of Time for Lyme, who addressed the issue of scientific bias and the importance of separating fact from opinion. She also emphasized that it was important to listen to patients drawing the parallel to the discovery of Lyme by Polly Murphy, a mother in a local community. Her testimony is available as a downloadable pdf by clicking the link at the bottom of this blog post.
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.
dear Diane Blanchard,
Here's a quote that I love (From Sue Morse, wildlife tracker) :
"Half of tracking is knowing where to look, the other half is looking."
The Lost Key
One night, a neighbor strolling by Nasrudin's house found him outside under the street lamp brushing through the dust. "Have you lost something, my friend?" he asked. Nasrudin explained that he had lost his key and asked the neighbor to help him find it. After some minutes of searching and turning up nothing, the neighbor asked him, "Are you sure you lost the key here?" "No, I did not lose it here. I lost it inside the house," Nasrudin answered. "If you lost the key in the house, Nasrudin, why are you looking for it out here?" "Well, there's more light out here, of course," Nasrudin replied.
**** *** **** *** **** ***
I am looking to better understand all the barriers in human medicine that prevent direct visual evaluation of tissue (histopathology etc) as a tool in evaluating the possibility of the persistence or relapse of disease after antibiotic treatment of tick-borne disease. Not on a patient basis, (as given the described paucity of organisms in proven persistent disease it may too time-consuming and invasive), but as an approach to trying to better understand the pathogenic mechanisms of persistent bacterial infections including lyme borreliosis. And to help validate clinical diagnostic tests. And possibly put an end to the controversy of whether chronic lyme borreliosis with the live organism causing active disease can occur in some people after the antibiotic regimans recommended by IDSA.
Background:
1. Animal studies suggest that the lyme organisms that survive standard antibiotic treatment are more likely to be found in deeper tissue such as collagen, and less likely to be found in bodily fluids such as blood.
2. Repeatedly, the absence of PCR-positivity in fluids such as blood or synovial fluid shortly after antibiotic treatment has been construed by journal article authors to suggest lack of persistent infection, although deeper tissues were not evaluated.
3. Histopathological studies in (untreated?) patients with persistent infection have shown that it can be very time-consuming to find the organisms, even when they are present, and well beyond the time limitations in a clinical laboratory.
4. If that is true with untreated patients with persistent infection, it is likely that it will be even more difficult in patients who relapse after antibiotic treatment.
5. From my perusal of the literature, please correct me and give references if this is in error, it does not appear that the proper tests—intensive studies of human body tissues-have been done to try to:
a. evaluate the possible persistence or relapse of Borrelia burgdorferi in some patients after the recommended antibiotic treatment (this may be true of certain other chronic , “low-grade” bacterial infections as well).
b. Evaluate the viability of such organisms and their ability to continue to cause disease.
6. It appears that several case-reports indicate the persistence of Borrelia burgdorferi after recommended treatment, often in patients who are not at risk for reexposure. However, I don’t understand why the IDSA committee did not give this evidence merit when evaluating the 2006 guidelines.
7.One organism can show disease differently in different species of animal; indeed one species may be quite susceptible to serious disease, whereas another may not get ill. Until we know the full spectrum of disease in humans, how can we be sure that any particular animal model adequately reflects the human situation? Until we intensely visualize the different manifestations of human disease by lyme borreliosis for example, how can we know the full spectrum of disease? Is there a tissue bank that collects samples from people with various stages/manifestations of lyme/possible lyme disease. If not, why not? Study of such tissues may not only further our understanding of lyme disease, but also show up other conditions and diagnoses that may have been missed.
IDSA appears to be wanting stronger evidence; perhaps a clincal study with proof that the same strain of borrelia is isolatable in patients (who have no risk of reexposure) after antibiotic treatment is virtually impossible on a non-research basis as the necessary tests ( such as histopathology, tissue PCR, typing, or culture etc) are not readily available on a clinical patient basis, and may require more “searching” time than available in a non-research setting.
7. Histopathology of patients with (untreated?) persistent lyme indicates that the disease causing organisms are often low in number in the tissues, and the time it took was beyond the capability of clincal labs. If that is true in untreated patients, the situation is probably even more difficult in individuals that have relapsed after antibiotic treatment. Just because it is difficult, does not mean it is scientifically impossible. There are ways this could be achieved-respond to this if you are interested in sharing ideas.
8. Will the controversy of ‘chronic lyme disease’ ever be put to rest without looking for the organism in the proper tissues? So much incredible work in many areas has been done so far and yet despite the many responses to IDSA’s call for public input, including the lengthy document by ILADS, the determination was for ‘no change’; not even for “we should look at this situation more carefully”.
9. If the IDSA committee does not accept what was submitted as proof that lyme disease can be a chronic active infection in some people after antibiotic treatment, they should be required to state exactly what kind of ‘proof’ they are looking for, and encourage and make possible the appropriate studies.
I would greatly appreciate any input from anyone who has first-hand knowledge about the barriers to direct-detection research in tick-born diseases in humans. As well I would appreciate corrections with references to any errors in what I have said.
Much thanks! here’s to the encouragement of wildlife tracking of the not-so-charismatic microfauna! as an adjunct in the study of this disease in humans.
kind regards,
‘Alice C. Evans’
lorraine,
would it be possible to edit diane's comments above to VERDANA OR ARIAL, size 12,
vs. illegible timesnewroman that runswordstogether likethisforme and other neuro folks?
thank you for your consideration as i know there more than me with this neuro problem.
diane, i heard you live; good job! thanks for being willing to do this on short notice for your 5 minutes of fame. 🙂 hugs
bettyg, iowa lyme activist
mdjunction lyme board group leader 🙂
Is there anywhere on the web where I can find the entire document that ILADS presented at the IDSA guidelines re-hearing? At the time the video testimony was online, I was too sick to save or watch anything. Now, I can't find the videos. Any direction I might look?