LYMEPOLICYWONK: IOM LIVE HEARING BLOG Part II
Please refer back to this site for new post on the hearings
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
Susan Connell, European equivalent of CDC
–Self appointed one man band more like, who is weilding far more power and control over doctors treating this illness than she should be allowed to do.
Pathogens beside Borrelia burgdorferi
Anaplasma
Babesia
Bartonella
Coinfections common?
–LRU does not test for all co infections and so would not have a clue as to whether they are common or not. Most doctors refuse to even test for co infections and not all these tests are available in the UK unless you are a dog.
Modern tests are quite good
–QUITE GOOD is not good enough if you are the person sick and refused treatment on the Quite good tests that come back false negative.
Late Lyme is quite responsive to treatment—even neurological MS presentation.
–Once again cherry picking science to prove her point. Where is the evidence to support this remark?
Searched for evidence of seronegative late Lyme if it occurs at all is extremely rare
–What real efforts has she made searching for evidence? If you don't look properly you won't find.
No reliable reports of seronegative late Lyme.
–Easy to say if she refuses to do further tests during long term treatments for patients with a clinical diagnosis.
Concerned about over use of laboratory tests
–So costs of tests is more important than helping patients find out what is wrong with them, not cost effective if they are left wallowing for years with chronic ill health that could be treated.
Concerned about the use of unorthodox tests and microscopy
–Why if it helps support a clinical diagnosis and the patient gets better from appropriate treatment?
CD-57 are not recommended because non-specificity
Tests are quite expensive for patients
–They wouldn't need to be if Dr O'Connell would open her mind to all available research and provide adequate testing on NHS.
Need more outcome studies
–Yes but designed to consider the possibility of Chronic Lyme rather than to support the denial of it.
Definition of chronic Lyme disease
–Oh so she does consider that there is such a thing, she should feel our suffering before playing god with our lives.
What about patients who have persistent symptoms without underlying infections which happens in other infections.
–Try proving there is no underlying infection, it is time that assumptions were put aside and science was allowed to prevail, until then let doctors treat the patients and not the test results.
–Sue O'Connell gets above her station, she should not be advising doctors to withdraw antibiotics when she has never even seen the patient or the patients response to treatment.Nor should she threaten doctors with the possibility of loosing their licence if they do not follow her advice.
Thankfully my GP did not agree with Sue O'Connells advice and followed ILADS guidelines. After nearly 3 years of antibiotics I have regained my health and my life. I was ill 6 1/2 years with chronic arthritis and muscle weakness it took 5 doctors and 3 rheumatologists 4 years to diagnose me. Then only after a chance course of antibiotics improved my symptoms more significantly than steroids had done. I had attended the surgery with bites, bulls eye rashes summer flu' and migrating arthralgias all documented on the computer. Other cases of Lyme Disease had been confirmed at my surgery. All that un necessary pain and suffering not to mention the loss of my income.
How many thousands more patients in the UK will suffer un necessarily whilst this self professed 'expert' sits at the helm.
i was 1 of 19 who were on the phones today when it started; they had made 50 phones dedicated to this.
i look forward to reading the written comments listening again; too much to obsorb in 4.5 hrs. LIVE.
thanks for making this available to all; i just sent your links to all my lyme list contacts to spread around.
bettyg, iowa lyme activist
40 yrs. chronic lyme
34.5 yrs. misdiagnosed by 40-50 drs.
UNACCEPTABLE!
I noticed that next to Susan O'Connell's name is the description 'European equivalent of CDC'. Is this what she has been describing herself as this plain wrong? Dr O'Connell is considered by the Health Protection Agency in London UK to be a Lyme expert (although in truth she works at a Lyme testing lab. in Southampton). The European Centre for Disease Prevention & Control however is a different entity and they are based in Sweden. The ECDC are happy to recognise that chronic forms of Lyme exist. For instance in their website they quote the following:
The clinical presentation of LB ranges from asymptomatic infection to serious "chronic" illness, usually affecting the skin, nervous and musculoskeletal systems, and rarely, the heart.
Stage III (months or even years after the tick bite). "Chronic" Lyme arthritis, lymphocytoma, acrodermatitis chronica atrophicans, encephalomyelitis or "chronic neuroborreliosis."
Susan O'Connell would never support this stance as she follows the IDSA policies to the letter and encourages other infectious disease consultants and family physicians to do so too.
With regards to treatment the European CDC has stated the following:
Treatment of the vast majority of LB cases is based on antibiotics, with drug type, dose, route (oral or intravenous) and duration "varying with the stage of the disease, as well as symptoms."
http://ecdc.europa.eu/en/healthtopics/pages/lyme_disease_factsheet.aspx
Why oh why then are patients in UK & Ireland stuck with treatment only suited to acute Lyme (stage 1 of the disease) when most of us have gone beyond that stage because of initial misdiagnosis? Why? Because Dr O'Connell insists that we follow IDSA guidelines of course!
Regarding Ms O'Connell's claim that Lyme tests are 'pretty good' this seems to conflict her current statement in a recent pubmed article which states the following :
"Further improvements in diagnostic tests would be welcomed."
http://www.ncbi.nlm.nih.gov/sites/entrez
In fact Trinity Biotech state themselves that their Elisa Lyme tests, if negative "should not be used to exclude diagnosis". Despite this, people with false negatives are told they simply 'don't have Lyme' even when other labs. confirm they do.
I don't know about you but I am mighty confused! Is there an elephant in the room?