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» LymeNet Flash » Questions and Discussion » Medical Questions » revised press release about Fallon Lyme study at Columbia

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Author Topic: revised press release about Fallon Lyme study at Columbia
pineapple
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CLARIFIED AS OF:
October 16, 2007*

Columbia University Medical Center Researchers Lead Placebo-Controlled
Study of Cognitive Impairment Among Patients
With Previously Treated Lyme Disease

NEW YORK - Researchers at Columbia University Medical Center have added to the body of literature on Lyme disease with the publication of a study entitled, ``A Randomized, Placebo-Controlled Trial of Repeated IV Antibiotic Therapy for Lyme Encephalopathy,'' in the Oct. 10 online edition of Neurology.

The study, led by principal investigator Brian Fallon, M.D., M.P.H., director of the recently established Lyme and Tick-borne Disease Research Center at Columbia University Medical Center, involved screening 3,368 patients for potential inclusion. Strict selection criteria included memory impairment and a positive IgG Western blot for Lyme disease at study entry, as well as previous antibiotic treatment for Lyme disease completed at least 4 months before study entry. The research was funded by the National Institute of Neurological Disorders and Stroke (NINDS).

Dr. Fallon and his research team identified patients with cognitive problems that developed after diagnosis with Lyme disease and that persisted or relapsed despite prior treatment. The goal was to determine whether patients who have already received the ``standard'' course of antibiotic treatment (three weeks of IV antibiotic therapy), would benefit from an additional 10 weeks of antibiotic therapy. They also set out to determine whether patients would relapse when taken off antibiotics or whether the alleviation of symptoms is sustained or enhanced with time.

After elimination of potential study subjects who did not meet inclusion criteria, only 57 study participants remained (37 patients with a history of Lyme disease and 20 healthy controls). They were divided into three subject groups: patients with a history of treated Lyme disease were randomized to IV treatment with an antibiotic called ceftriaxone for 10 weeks; patients with a history of treated Lyme disease were randomized to IV placebo for 10 weeks; and, healthy controls were tested at the same time points as the patients to help to control for the practice effect on neuropsychological testing.

``We set out in this study to learn if a repeated course of antibiotics relieves certain symptoms associated with post-treatment chronic Lyme encephalopathy and to assess whether such symptom relief is sustained after patients are taken off antibiotics,'' said Dr. Fallon. ``The sample group of 23 patients who received 10 weeks of IV ceftriaxone therapy initially showed moderate improvements in cognition when evaluated at the primary outcome assessment point of 12 weeks; however, the improvement in cognition was not sustained in the 6 month (24 week) assessment.''

According to the paper, patients with greater severity of pain, fatigue or physical dysfunction at the start of the study who were randomized to ceftriaxone treatment reported improvement in these symptoms at week 12, as compared to those patients who were given IV placebo. For a subset of patients who received IV ceftriaxone who started the study with higher levels of pain or physical functioning impairments, the improvement in pain and physical functioning was sustained to week 24. Whether reported improvement was due to a direct antimicrobial effect of the antibiotic or effects on neurotransmitters is unclear. Of concern in this study is that IV ceftriaxone treatment was associated with serious side effects in about one-quarter of the patients.

The paper concludes, ``...considering both the limited duration of cognitive improvement and the risks, 10 weeks of IV ceftriaxone and then 14 weeks of no antibiotic is not an effective strategy for sustained cognitive improvement.''

- ### -

Columbia University Medical Center provides international leadership in basic, pre-clinical and clinical research, in medical and health sciences education, and in patient care. The medical center trains future leaders and includes the dedicated work of many physicians, public health professionals, dentists, nurses, and scientists at the College of Physicians & Surgeons, the Mailman School of Public Health, the College of Dental Medicine, the School of Nursing, the biomedical departments of the Graduate School of Arts and Sciences, and allied research centers and institutions.

PATIENT QUERIES:
- To schedule a research evaluation for possible participation in a research study, please call the Lyme and Tick-borne Disease Research Center at 212-543-6510.
- Please note: As of June 4, 2007, the center is not currently conducting any active treatment trials.


* The press release distributed on 10/10/07 regarding the publication of this study has been clarified above to reflect the conclusions noted in the Neurology paper. Members of the media may reqeust a copy of the full study by contacting Angela Babb, media and public relations program manager, American Academy of Neurology, at [email protected] or 651-695-2789.

Posts: 339 | From nowhere | Registered: May 2007  |  IP: Logged | Report this post to a Moderator
8man12
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Another study that doesn't make a big enough statement too help any of us.
WE need to have someone find what ticks are carring that isnt cureable in many lyme patients.
There has to be more tick borne diseases not known to man at the present.

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bettyg
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//////The paper concludes, ``...considering both the limited duration of cognitive improvement and the risks, 10 weeks of IV ceftriaxone and then 14 weeks of no antibiotic is not an effective strategy for sustained cognitive improvement.''

- ### -.......... HOG WASH !!

idsa had to find some fault, so chose this way! [cussing]

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5dana8
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Hi Pinapple [Smile]

I am confused...which isn't hard to do today ...am herxing [Frown]

Who "clarified" this study? Who wrote this article?

--------------------
5dana8

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Greatcod
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This is not the IDSA, this is Fallon saying that the 10 weeks of IV was not justified by the short term improvement in cognition it provided.
Not good news, not at all.
The issue of longer term treatment--IV ABX of six months or more, when the sustained improvement seems to occur, may never get studied formally.

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painted turtle
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Maybe Dr. Fallon is smart enough to find justification for another study that would include

Paramaters he hadn't addressed in this study.

He may also include additional arms, on top of the IV abx, such as actual cognitive therapy and brain exercises, or etc.

Depending on severity of patients.

Dosen't seem that the more severely ill would be included in these studies though, so doesn't seem any dangers there.

Also taking into account co-infections and other things that may contribute to a persons lack of progress.

Based on this study, I hear what he says. The risk and lack of sustained improvement does not warrant the treatment and he thinks other things need to be discovered to treat the condition

I think Dr Fallon is smart enough to figure out what these other things are

In addition to antibiotics, after a certain period of time.

I think the hardest decision to make is exactly when to go off antibiotics. It's clear that this disease once having reached a certain point

I tenacious as tenacious gets.

I think further research will be done for the future,

Just that it doesn't help us now, is all.

--------------------
www.lymefire.blogspot.com

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AliG
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Maybe it's me.

When I read that, I see that stopping ABX altogether after 10 wks is not effective to sustain improvement.

I would think that means they need to research switching to orals at that point or staying on IV longer. They need to find a way to maintain the improvement. No?

My LLMD is planning to try maintaining me on 1 wk/month Azithromycin, once we get rid of the symptoms. He shipped me off for IV, but I'm to return to him when I'm through with it.

Sure the ducks could continue to interpret that as a deterrent to IV, but they would probably interpret ANY study that way. [bonk]

--------------------
Note: I'm NOT a medical professional. The information I share is from my own personal research and experience. Please do not construe anything I share as medical advice, which should only be obtained from a licensed medical practitioner.

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Soleilpie
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quote:
Originally posted by Greatcod:
This is not the IDSA, this is Fallon saying that the 10 weeks of IV was not justified by the short term improvement in cognition it provided.
Not good news, not at all.
The issue of longer term treatment--IV ABX of six months or more, when the sustained improvement seems to occur, may never get studied formally.

Or it could mean that 10 weeks isn't enough. Fallon states that, "10 weeks of IV ceftriaxone and then 14 weeks of no antibiotic is not an effective strategy." So, 10 weeks on and 14 weeks off isn't working. What about 15 or 20 weeks on and then 14 weeks off? Maybe cognitive issues are slow to respond compared with those symptoms involving pain, fatigue & physical dysfunction.

I know that Fallon also mentioned in a round about way that the risks may outweigh the benefits, but there are always serious risks when IV anything is used. Poking through our 1st line of defense, the skin, and then into a large vein can very easily introduce unwanted microbes. And then leaving IVs in for days or months increases that risk. IVs involve serious risks anytime they're used. It doesn't matter what illness it's used for. It's just that for some illnesses, the benefits for IVs for outweigh the risks.

Keep in mind that Fallon's study only involved the use of an IV antibiotic. Orals weren't considered. There are also risks with oral antibiotics, but not near the risks with IVs.

Most of you Lyme patients know from experience that you have regained some of your life back because of IV & oral antibiotics. This study only looked at 37 patients w/confirmed Lyme, so sample size was definitely a limitation in this study.

Please don't get discouraged. Fallon is only stating what his data showed. He hasn't come out and said that the use of long term antibiotics shouldn't be considered. He's just saying that 10 weeks of IV abx and then off 14 weeks didn't keep the symptoms at bay for those with cognitive issues.

Here, maybe this will help some of you:
"Fallon said, however, that even if -- for the sake of argument-- he agreed to yield on the issue of chronic infection, his study and others still show that people with Lyme symptoms get better if they take antibiotics."

You can find that statement in the article linked below:
New study shows help for Lyme disease

--------------------
The best index to a person's character is how he treats people who can't do him any good, and how he treats people who can't fight back.
-Abigail van Buren (Pauline Esther Friedman) (1918-2002)

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ldfighter
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http://www.cumc.columbia.edu/news/press_releases/fallon_neurology_lyme_disease.html

Fallon is at Columbia, but he's not writing the press releases. It was Columbia's news office that revised it to put an IDSA spin on it, the question is who they caved to and why.

The statement at the bottom that it was revised to reflect the paper's conclusions is a total lie, because they also deleted statements about the severe disability Fallon found among patients which was highlighted in the first press release.

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5dana8
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Thanks Idfighter [Smile]

Thats a relief. I knew Dr. F would not write such garbage. Shame Shamne Shame on whoever at Columbia wrote this. I think we should send it to Pat

Does anyone know how to forward this to her?

--------------------
5dana8

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5dana8
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Could someone please pm me with her e-mail address. I would like to send this link to her. I have left some of my will donated to the columbia center but now am having second thoughts

thanks
Dana

--------------------
5dana8

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ldfighter
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Here's the Columbia news office's contact info.

Phone: 212-305-3900
Fax: 212-305-4521
[email protected]

http://asp.cpmc.columbia.edu/fp/Profile.asp?ID=37

I don't know if the media contact people at the top of the press release are the ones to contact or not, but their emails are on the press release (link is above).

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bettyg
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dana,

here is pat smith's email: [email protected]

itis also on all LDA brochures, etc. [Wink]

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5dana8
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Thanks Idfighter & Betty [Smile]

I really appreciate the contact info

Blessings [Smile]
Dana

--------------------
5dana8

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Aligondo Bruce
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you guys might want to hold off of drawing any firm conclusions from the recent fallon paper until he's published the paper that goes along with it, which is a study of PET and MRI scans before, during, and after treatment of these patients.

only 3 of the fallon patients had a history of meningitis or encephalitis. most of the patients studied were arthritis patients who had continuing problems after therapy.

this situation is far more complex than is being portrayed. there apparently is a difference between what was studied in this fallon paper, which is post-treatment arthritic lyme, and CNS lyme disease which involves significant brain pathology.

what they've done so far is hodge-podge everything together based largely on the CDC WB criteria which are deeply flawed and heavily biased toward early arthritic disease. fallon was forced to work within these parameters.

CNS lyme disease is a difficult entity to characterize, because it is known that elisas, blots, pcrs, etc. can all be negative in neuroborreliosis which is active, at least by CDC standards. this is because lyme is a deep tissue infection in later stages and probably involves intracellular aspects.

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Greatcod
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"and CNS lyme disease which involves significant brain pathology."

You might want to check out IDSA Lyme guidelines.
Their defintion of neuroLyme is very very narrow.

The kind of brainfog that most of us experience doesn't count, according to them.

I had no idea that so many in the study had chronic Lyme arthritis...I am guessing that Fallon understood that in order to give the study legs, he had to select a population that met the very stringent criteria of the IDSA and Steere.

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andie-ws
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No surprise in Fallon's report.

We know that lyme is a bacteria that manifests in different forms.

Even tho prolonged iv rocephin will initially kill some spirochetes, it will trigger others to evade the hostile environment, go into survival mode and morph into cyst form.

Thus producing a temporary remission of symptoms.

Which is why Fallon's patients experienced moderate improvement at 12 weeks.

But, rocephin does not kill the cyst form.

So, after treatment with rocephin stops, the cysts open, releasing spirochetes, which results in a return of symptoms.

This biologic process is very likely why the patient's moderate cognitive improvements seen at 12 weeks were of limited duration and not sustained at 24.

At a minimum, multiple antibiotics, including cyst busters (like flagyl) are needed to get rid of lyme.

IV rocephin represents but one step oin a multiple step process to eradicate the bacteria.

Complicating the clinical picture for complete recovery from impairment is the amount of damage already sustained from the initial infection and the presence of co-infections.

All that said, there is no doubt in my mind that in this heated political/medical debate, the IDSA will use any part and parcel of Fallon's study to discredit llmds and prevent presciptions for antibiotics.

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Greatcod
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Exactly--they will pitch it as verifying Klempner's study-I think that treatment there involved a month of IV ABX.
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Aligondo Bruce
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quote:
Originally posted by Greatcod:
"and CNS lyme disease which involves significant brain pathology."

You might want to check out IDSA Lyme guidelines.
Their defintion of neuroLyme is very very narrow.

The kind of brainfog that most of us experience doesn't count, according to them.

I had no idea that so many in the study had chronic Lyme arthritis...I am guessing that Fallon understood that in order to give the study legs, he had to select a population that met the very stringent criteria of the IDSA and Steere.

you know this, that the IDSA neurolyme dx standards are very narrow and are aimed at people who have a certain type of disease...mainly early, acute disease involving a nerve palsy, or acute disease manifesting as a meningitis in which CSF testing is positive. however in the past they have all written that CNS disease cannot be excluded by negative CSF testing. what is being excluded here are the encephalopathy patients...the late stage patients.

I'm not at all certain that post-lyme 'fatigue', or the chronic lyme patients studied by fallon lately, are the same thing.

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Aligondo Bruce
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quote:
Originally posted by Greatcod:
"and CNS lyme disease which involves significant brain pathology."

You might want to check out IDSA Lyme guidelines.
Their defintion of neuroLyme is very very narrow.

The kind of brainfog that most of us experience doesn't count, according to them.

I had no idea that so many in the study had chronic Lyme arthritis...I am guessing that Fallon understood that in order to give the study legs, he had to select a population that met the very stringent criteria of the IDSA and Steere.

more than 80% studied had an arthritis history.
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Keebler
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-

Thanks for the info. - it's really a bit of a kick in the stomach for those with Neurolyme and other CNS symptoms.

I was so hoping for something that I could take to my doctor to explain this sad reality and, hopefully, fuel the doctor to help. (Unless it's published in NEJM or JAMA, he won't read it, though.)

It's sad if the press dept. edited Fallon's own release. That's what the media will pick up.

Where is all the research is that shows the life-cycle and various forms of the spirochete, etc. ? How is that always forgotten?

It should be the opening statement in every lyme article - for education purposes. Is MacDonald's research discounted ?

and - andie-ws - thanks for your thoughts on the process.

It's like giving firefighters only half the needed tools and them blaming them if the fire flairs.

Well, for Halloween, I want to be a healthy person. And make Halloween like the "GroundHog Day" movie - over and over.

-

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Greatcod
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"more than 80% studied had an arthritis history"

Those are what Steere and IDSA calls "Chronic Lyme Arthritis". I'm in over my head on this, but Steere has published a bunch about one haplotype, HRL-4A, or something like that, being treatment resistant. He speculates that their continuing problems are caused by autoimmunity.
Those with chronic Lyme arthritis and the very few with the IDSA version of neuroLyme define the Lyme chronic population for Steere and the IDSA. Leaves out hundreds of thousands of people.

This whole damn Steere IDSA Lyme thing is sickening ..criminal.

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B R H
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The reason these "tick borne illnesses" can be so difficult to test for & cure is that there is not one single pathogen responsible for chronic inflammation! Borrelia species "shares" plasmids within the "DNA soup" we call our bodies. The "strongest" have attained the ability to hide within the very cells that are supposed to kill them. Trevor Marshall's pathogenesis for chronic disease clearly explains the process & has led to a potential cure as well.
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B R H
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quote:
Originally posted by Greatcod:
"...their continuing problems are caused by autoimmunity.

Do you really believe there is such a thing as "immunity to self"? Do you think it is more likely that our bodies are trying to destroy themselves or that they are trying to destroy an evasive pathogen?
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Greatcod
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The autoimmunity thing is Allen Steere's, not mine.
I believe in continuing infection, but it may be more than that..the syphilis spirochete goes dormant for decades. Mabe the Lyme bacteria is doing the same thing. Nobody knows the whole picture, by any means.

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david1097
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The results presented in fallons study are the results, like it or not.... We'll have to see what they are once the report is available....That being said the school is not going to risk being vetted from future funding because of one guy, who I am sure is feeling some heat from the administration....

That being said, there is however a way to resolve all of this "persistent vs post lyme" stuff, that is if the researches have the guts to try it...

Immunosupress some of the chronic cases via corticol steroids (also relieving the symtptoms in the process)or other means and see what if any disease emerges.

A good cheap option is Prednisone which is well known for reactivating "cured" diseases that are latent or "dormant" such as TB.

In this regard I have often wondered why steere et al recommend NSAID as post lyme treatment when in an acute attack
(and I strongly believe that post lyme is only active infection if it has relapsing-remitting symptoms)
prednisone will fix it in minutes and will fix it far better then will NSAID's (which usually does nothing except in some joint cases.)

Further adding to this Steere mystery is that periodic use of prednisone is not a significant risk unless there is something lurking in the background, plus its cheap.

Perhaps they know something that they don't want the public to know.

So much bu11 sh1t around, but such a small shovel....

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