LYMEPOLICYWONK: Pat Smith’s Comment before IOM
I am posting the written speeches of those who commented during the public comment period of the IOM. The speech below is that of Pat Smith, President of the national Lyme Disease Association, who addressed process issues with the IOM hearing and raised concerns regarding the lack of transparency of the process and the need for a greater opportunity for patients and other viewpoints to participate in the hearings. Her testimony is available as a downloadable pdf by clicking the link at the bottom of this blog post.
April 29, 2010 IOM Lyme Disease Panel Statement
I’m Pat Smith, president of the national non profit Lyme Disease Association which funds research and education grants, partners with the Environmental Protection Agency PESP Program on prevention for high risk groups including children and which collaborated to open a Lyme disease research center at Columbia University. LDA works with 36 organizations nationwide on Lyme disease. I would like to spend the entire 5 minutes of my time talking about the science, but in good conscience I think I need to address the process and other issues central to this hearing.
2010 Labor HHS appropriations language adopted by Congress clearly directs this IOM process. NIH assured me in discussions that the process would be one that Lyme organizations would find in compliance in every way with the intent of that language, including a guarantee that this process would be totally open and public. IOM told me that adequate time would be allotted so that all public comment would be heard. The only public comment time is 5 minutes, hardly adequate to cover crucial topics that need addressing and has even discouraged those geographically distant from attending.
Instead of providing an unbiased panel on this most controversial topic, IOM indicates bias is not relevant thus isn’t considered in panel selection. However, balance is stressed by IOM, yet the chosen panel does not represent the diverse viewpoints that exist on selection and interpretation of existent scientific Lyme research. Several individuals are clearly associated with entities that hold preconceived ideas about Lyme, especially chronic Lyme. LDA and other organizations sent IOM recommendations for panel members, none of whom were selected, and later sent concerns about imbalance in the chosen panel, including recommendations to provide that balance. That issue has not been addressed to date.
We also articulated concerns that anonymous reviewers will be allowed to present input on the panel report. “As a final check for quality and objectivity, all IOM reports undergo an independent external review by a second, independent group of experts whose comments are provided anonymously to the committee members.” According to an IOM official “The reviewers will not sign their names to their reviews and thus, be free to review the report as they read it. The committee responds to the review and the final report is published.” The panel and public are unaware of reviewers’ identities until after the fact and unaware of which reviewers provided which comments. It is unclear if the outside review itself is made public. Bottom line, the concepts of transparency and accountability go by the wayside.
Appropriations language requires the September meeting to address the state of the science. To that end, we want to ensure that science considered not only includes basic science, animal model, human clinical trial, but also clinical evidence from practicing physicians, a group that has been under represented in the Lyme disease science to date.
Additionally, it is important that the panel consider limitations of any evidence presented even that from controlled trials created by small sample sizes and whether the study’s findings
Are compromised by loss to follow-up
Are consistently confirmed by other studies,
Are clinically relevant,
Lack generalizability due to restrictive sample selection criteria,
Are statistically meaningful, and whether
Its conclusions are supported by the findings or represent the author’s opinion.
We believe the following areas of science require inclusion in the September public workshop session. Testing is of priority importance, since its sensitivity remains in question. Peer review and other data [i]supports the conclusion that the recommended ELISA does not pick up enough patients to be a screening test, with issues of timing of the test, antibody/antigen complexes,[ii] effect of treatment on test results, strain variations, and other factors.[iii] Persistence of infection needs to be explored, including in-depth examination in animal models of mechanisms of persistence and [iv] , [v] , [vi] establishment of criteria for a specimen bank that includes samples inside and outside the CDC criteria.
At the workshop’s conclusion, please ensure that all diverse viewpoints are included in any report, areas of divergence are identified, the limits of the existing science are demarcated, and research opportunities are highlighted. In addition, all information provided to the panel and the identity of the contributing source of that material should be made public.
We believe that no information should be anonymously provided to the panel given the highly polemic nature of this debate. Also, since the intent is state of the science, the conference summary should be related to what is lacking in the science area, and gaps and limitations in science should not be filled with expert opinion of the panel. In short, this is not a consensus conference, the science is still unfolding, and it would be irresponsible for anyone to “call” the science. Thank you.
[ii] S. Schutzer et al, Lancet 1990, Journal of Clinical Investigation 1994 & JAMA Vol 282, No. 20 Borrelia Burgdorferi: Specific Immune Complexes in Acute Lyme Disease, Nov. 24, 1999; also in JCI
[iii] P. Coulter et al, J. Clin Microbiol.. 2005Oct.; 43(10): 5080-4 Two Year Evaluation of Borrelia burgdorferi Culture and Supplemental Tests for Definitive Diagnosis of Lyme Disease
[iv] S.W. Barthold et al, Infection and Immunity, Aug. 2006 Antibody-Mediated Disease Remission in the Mouse Model of Lyme Borreliosis
[v] RK. StraubingerJournal of Clinical Microbiology, June 2000, PCR-Based Quantification of Borrelia burgdorferi Organisms in Canine Tissues over a 500-Day Postinfection Period
References and further reading may be available for this article. To view references and further reading you must purchase this article.
[vi] M Embers, MT Philipp et al, Microbes and Infection, 2004 Survival strategies of Borrelia burgdorferi, the etiologic agent of Lyme disease
lorraine and staff,
thank you for taping these LIVE today; i'll listen again to them as i heard them LIVE ON PHONE.
i was 1 of 19 on the phones at the beginning; 50 max was limit so i was surprised only 19 of us were on there.
when i was notified, i sent to those on my lyme list group immediately.
much was hard to hear; so this will make sense of what i was unable to understand!
my highlite was someone saying they should check w/george w. bush as to who treated his lyme disease and get that information for ALL lyme/co-infeciton people.
bettyg, iowa lyme activist
re: 'establishment of criteria for a speciman bank that includes samples inside and outside the CDC criteria":
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."
also:
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’
thanks for keeping us updated