April 29, 2010 Patricia V. Smith, President, Lyme Disease Association, Inc.
Testimony to: Institute of Medicine (IOM)
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 my five minutes talking about the science, but in good conscience, I can’t do that and need to also address the process issues.
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 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, effect of treatment on test results, strain variations, and other factors. Persistence of infection needs to be explored, including
in-depth examination in animal models of mechanisms of persistence and  ,  ,  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.
 According to a letter from the NY DOH to the CDC, if NY had followed the 2-tier testing requirement
for a particular year─ a + ELISA then followed by Western Blot─ 81% of non-EM cases would not have
 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
 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
 S.W. Barthold et al, Infection and Immunity, Aug. 2006 Antibody-Mediated Disease Remission in the
Mouse Model of Lyme Borreliosis
 RK. Straubinger Journal 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.
 M Embers, MT Philipp et al, Microbes and Infection, 2004 Survival strategies of Borrelia burgdorferi,
the etiologic agent of Lyme disease