LYMEPOLICYWONK: IOM LIVE HEARING BLOG Part II

Byldoadmin

12:40 pm EST: Jill Harper, Office of the Director, National Institute of Allergy and Infectious Diseases gave the charge from the NIAID to the IOM committee

Tests are insensitive

Chronic manifestations of Lyme disease

Some animal studies evidencing persistence, but not clear importance of these

Need to focus on mechanisms of pathogensis of disease and better lab tests

NIAID to sponsor scientific conference

Broad spectrum of view on LD

Forum for public input

Public participation

We ask that the forum provide a forum for public input

Broad participation accessible via web pass

And to include participation of people with lyme disease

Summary of the current state of the science

Q: Coinfecitons

A: NIAID does not want to drive the answer of the breadth of this inquiry

Q:  Are we charged with looking at the body of information related to symptom complexes

Persistence of infection is important

The relationship between the infection and symptoms

Q: What to include and not include

Treatment guidelines

Diagnostics

Case definitions

Research agenda

Vaccines

A.      Treatment guidelines:  should not cover treatment guidelines  at the time we drafted the statement of work for this the feeling was a separate forum for that –it is not intent to completely ignore treatment issues

B.      Diagnostics, vaccines, case definitions, –input from other agencies would be useful

C.      Research agenda:  publicly available summary

Q the objective and use of the final report

The ultimate purpose and format  of report—we do see meeting summary as something that all agencies can use as what we do and don’t know about these diseases—where the gaps and the opportunities might be—to identify areas most needed for scientific research

Q how will it impact NIH

A useful document on where the most interest is in research

There have not been a lot of opportunities for patients to have input—unique perspective to help

1:30 pm EST Susan Connell,  European equivalent of  CDC

Pathogens beside Borrelia burgdorferi

Anaplasma

Babesia

Bartonella

Coinfections common?

Modern tests are quite good

Late Lyme is quite responsive to treatment—even neurological MS presentation

Searched for evidence of seronegative late Lyme if it occurs at all is extremely rare

No reliable reports of seronegative late Lyme

Concerned about over use of laboratory tests

Concerned about the use of unorthodox tests and microscopy

CD-57 are not recommended because non-specificity

Tests are quite expensive for patients

Need more outcome studies

Definition of chronic Lyme disease

What about patients who have persistent symptoms without underlying infections which happens in other infections

 

1:45 pm Ben Beard, CDC

2020 Goals

Strengthening national surveillance

Prevention

Improving diagnosis and treatment

Prevention

                Need for better data for explanation for drivers for trends we need

                Need for improved diagnostics

We do not know the extent of underreporting

We have no basis for showing we can reduce human cases

Diagnostic difficulties

Lack of sensitivity early in infection

Difficulty distinquishing active infection from prior infection

Identification of other agents in ticks

What are the pathogens in ticks responsible for human illness

What diagnostics are needed to detect

Vaccines

Safety

Efficacy

Costliness

 

 

Sally Hojvat, FDA

There is no perfect diagnostic test

What are the risks of false positive

Class II manufacturers have to send in information for them to review

Factors include:

Analytical reliance and accurate

Performance in an intended population

How sensitive test

Tests approved by FDA to date:

4 commercial test through FDA

IFA

IgG

IgM

ELISA 52 have been approved

WB 20 have been approved

No PCR  approved through FDA: therefore only home brew or lab test

Strain differences between US and Non US strains

Should the two step process be changed to a one step process

No one step tests submitted so far have shown greater efficacy than two step

Problems include

Lack of available FDA PCR test

Lack of well characterized serology specimens for instance indicating stage or length of illness

Multi-organism testing

Ask for data on each and cross reactions from putting together in one test

No FDA approved

Culture

Skin biopsy

Non-commercial assays

DOD, CDC have own assays

 

 

Patti Bright, Wild Disease Coordinator

US Geological Survey

More than 90% of vector borne diseases

Focus of research should be environmental factors

Environmental impact of control efforts such as pesticides

Research to understand eco factors that affect tick abundance and distribution

Identification of reservoir hosts

More invasive strains are transmitted in milder climate circumstances

Elizabeth Blood, NEON Program Director

This is a highly technical talk on research and information from satellite and ecological project useful for modeling large scale factors to help interpret the information by CDC and local health department to be able to understand critical drivers like climatic changes.

John Carroll, Entomologist, US Dept of Agriculture

Adalberto Perez de Leon, Laboratory Director,  US Dept of Agriculture

Deer targeted technologies.  Deer can feed many ticks and serve as host.  The reproductive strategy is where female lays many eggs but few survive.  Relatively few adults compared to nymphal ticks.  Relatively few adults feeding on relative few deer (particular type of tick)

Tick vaccines and contraceptives to treat white tail deer to deliver to ticks.  This is all pretty interesting about opportunities to control tick population through pesticides, vaccines, and contraceptives.

Montira Pongsiri, Environoment Health Scientist, EPA:

The ecology of Lyme disease—the nymphs plays a larger role in transmission.  How does the diversity of hosts affect tick abundance? Take an interdisciplinary science approach, because want their research results implemented.  Perhaps we can identify modifiable eco-factors that influence disease, land use disruption and change and disease spread.  We have developed through private public partnership processes to control pests. 

Public Comment Period

Dr. Weinstein—no show

Pat Smith–t

Greg Skall

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