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» LymeNet Flash » Questions and Discussion » Medical Questions » Clinical trial using disease free ticks?

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Author Topic: Clinical trial using disease free ticks?
Pinelady
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http://clinicalstudies.info.nih.gov/detail/A_2010-I-0139.html

--------------------
Suspected Lyme 07 Test neg One band migrating in IgG region
unable to identify.Igenex Jan.09IFA titer 1:40 IND
IgM neg pos
31 +++ 34 IND 39 IND 41 IND 83-93 +
DX:Neuroborreliosis

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jkmom
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[Eek!]

Who would let 20 - 30 "disease-free" ticks stay on them?

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JR
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Fascinating

It occured to me -what if it's possible for Human to Human transmission via tick?

Scenerio-
I'm sitting on the couch. I have Lyme Disease.
A disease free tick is attached (unbeknowngst to me) The once disease free tick now carries Lyme Disease. Falls off onto the couch.
And two days later attaches itself to my daughter who is now sitting on the same couch...

I wonder if this has ever been considered?

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lou
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How can they be sure these ticks are disease free? Considering how poorly current testing is at picking up diseases, this sounds dangerous to me.

And they are not going to be using people like most of us who don't produce antibodies anymore. That is the group they should be looking at.

Plus, a recent study showed that it wasn't necessary for whole spirochetes to be present, that compounds produced by keets could cross the blood brain barrier and cause inflammation by themselves, which is significant since they keep harping on the fact that few keets can be found in this unaccountably still sick people.

And no investigator listed. So, is this in-house, with the same NIH employee who has been studying us for years and never once published anything useful.

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marypart
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I don't know anything about the scientist at NIH,
but this study is a terrific idea as a follow-up to an earlier study involving mice. In that study, mice with lyme were treated with antibiotics until they appeared to be free of Lyme. Then clean ticks were put on them and they gave Lyme to the ticks. This kind of research PROVES OUR POINT that while the Lyme is difficult to see, it still exists and has not been eradicated. A human study is a great idea. I just hope that the study has the same result as the mice study.

Here is the link to the study on mice:

http://www.medscape.com/medline/abstract/18316520


-Mary

--------------------
Son, 26, Dx Lyme 4/10, Babs 8/10
Had serious arthritis, all gone.
Currently on Valtrex
Daughter, 26,bullseye 7/11
arthritis in knees, cured and off all meds. .
Self:Lyme, bart, sxs gone, no longer treating.

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lou
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Yes, it is an idea, but it all depends on who the investigator is. If it is not honest, unbiased person, then it may be an attempt to discredit the study you mentioned, marypat. You are too new to lyme to understand this, probably.
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Keebler
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-
Along with lou's comments, a huge factor is that it is impossible to really know if a tick is disease free. There are so many tick-borne infections and the tests are not all that accurate. There are some infections for which we don't even have tests.

How in the world can they guarantee that a tick is totally disease-free?

Even if, in their stupidity, they only consider lyme, there are many strains of lyme - over 300. And we test for just one of those, Bb.

Lyme also has so many ways to evade testing, so many different cycles and forms.

And, if participants DO get ill, the tests are not going to really show that. They will be told it's psychological and be given an antidepressant that will ruin their liver and irritate their brain and mess up their nerve tissue functions.
-

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jkmom
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And do they even acknowledge all of the other tick-borne diseases?
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Lonestartick
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I think this is exciting news.

Naive ticks are not collected from the wild, but are lab raised in pure, controlled conditions for the purpose of research. They are available commercially, just as naive medical leaches and lab mice are widely available.

This is valuable research capable of expanding upon Barthold's work at UC Davis demonstrating the persistence of the disease in culture negative patients who are currently denied treatment based on negative tests. Xenodiagnosis is a valuable tool in research because it can demonstrate infection in circumstances where culture, PCR and other testing methods fail.

The lead researcher is, in my opinion, a sound scientist who has a history of publications on antigenic variation and immune invasion in Lyme disease. He also helped to identify the role of matrix metalloproteinases in Lyme Disease.

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nenet
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Once again, the study design is flawed at its very core (in my opinion), as the Inclusion Criteria are based on IDSA Lyme diagnosis guidelines, and CDC epidemiological case study definitions.

Those that present with the EM and positive serology, to IDSA and CDC case definition standards, may have entirely different strains that may not behave in the same manner as possibly more virulent or persistent strains.

There also could be other factors that might explain the differences in EM- and sero-negative Lyme patients and those that are positive; these factors might also have an effect on the relevance of this study's outcome.

If they would just include those with a clinical diagnosis but negative serology and no EM rash, that would help narrow the data gap.

As it is designed now, the study will exclude Lyme patients that fall comfortably within the CDC's own recommendations for reliance on clinical diagnosis over serology.

Currently there is a poor understanding of the pathogenesis of this disease, and its various strains and sub-strains, so that starting out with these assumptive Inclusion Criteria could be wreaking havoc with the data pool, and setting us all up for another study failure.


Another problem I see is their "healthy" control group. One wonders how they confirmed lack of asymptomatic Lyme infection in that control group, seeing as this study is in part an attempt to solve the issue of not being able to prove the absence of Lyme infection via current testing methods.


Why has this circular logic become so widespread in academia and the scientific community when it comes to Lyme research? Why does no one in the journal peer groups or research departments point out the blatant contradictions? The intent of the study looks so promising, I just wish its human/medical element were more carefully considered.

[ 07-25-2010, 03:25 PM: Message edited by: nenet ]

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kday
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Well said nenet. Couldn't have said it better.

I also think that this study is a threat to human/public health.

What method do they use to sterilize the ticks (without killing them) to ensure that they are disease free. Will these "disease free" ticks cause more symptoms, and will the new symptoms be identified as psychosomatic in absence of positive serology for other infectious diseases?

Flawed, flawed, flawed. I don't like this study at all. Not only do I think this study can be a threat to the participant, but what if a tick becomes infected and clings to a family member. Is the study to be done in a controlled, isolated environment?

This study needs to be thrown out.

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supergirl
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i feel to worried about this kind of thing getting into the wrong hands... we are walking ticking time bombs, so to speak.

All I wanna do is get well and share my story as I go along. I don't want my spirochetes getting into the wrong hands and used for harm, somehow. Be cautious with this one, please.

--------------------
PHOENIX: mythical bird that rises from the ashes
July '09 got sick very quickly could barely get out of bed - ND diag lymes.. and the journey began
bite: unkown - no rash

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lou
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Lonestartick, where do you see the name of the investigator? I cannot find it on this announcement.
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marypart
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Here's a link from clinicaltrials.gov with a bit more info about the study, although I don't see the authors listed.

http://clinicaltrials.gov/ct2/show/NCT01143558?term=lyme&rank=7

I'm excited to see that NIH is even considering the idea that the bacteria is still alive. I'm new to the Lyme scene, but I've been studying a very similar controversy in Reactive Arthritis for over a decade.

I think the Lyme controversy is going to be helped by the fact that there have been quite a few recent studies showing that longterm antibiotics are helpful in Reactive arthritis caused by other triggers. Xenodiagnosis is being used to prove the presence of the bacteria (or virus) in those other cases as well.

Chlamydia Trachomonis and C. Pneumonia are a couple of examples that have the best evidence for ongoing stealth infection. One study in February this year showed that Reactive Arthritis patients whose symptoms had been triggered by chlamydia, with an average duration of illness of 10 years were helped by longterm antibiotics. A few people went into complete remission.

I fully believe that in five years every Rheumotologist in the country will be searching for ongoing infections of some kind in all of their patients. This doesn't mean that auto-immune processes do not exist... but the underlying bacteria are still there.
-Mary

--------------------
Son, 26, Dx Lyme 4/10, Babs 8/10
Had serious arthritis, all gone.
Currently on Valtrex
Daughter, 26,bullseye 7/11
arthritis in knees, cured and off all meds. .
Self:Lyme, bart, sxs gone, no longer treating.

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onbam
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Simply insane. Ticks can pass it to their offspring.
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lou
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OK. No investigator listed, but here are the recruiting locations and none are home to people who believe in chronic lyme. It goes on for FIVE years!

Locations

United States, Connecticut
Yale University Recruiting
New Haven, Connecticut, United States, 06510-8005

United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892

United States, Massachusetts
Tufts University Recruiting
North Grafton, Massachusetts, United States, 01536

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Pinelady
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Now you reckon they want to talk about "No Scientific Evidence"???

--------------------
Suspected Lyme 07 Test neg One band migrating in IgG region
unable to identify.Igenex Jan.09IFA titer 1:40 IND
IgM neg pos
31 +++ 34 IND 39 IND 41 IND 83-93 +
DX:Neuroborreliosis

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JR
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Now Now I'm sure all the ticks are given the ONE DOSE DOXY treatment before using them-just in case.
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