sometimesdilly
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posted
knocking down baker's charges that study participants included made any (disagreeing) studies invalid.
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sometimesdilly
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posted
"Krupp made a mistake" straight on
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sometimesdilly
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posted
transmission/LN down for a moment for anyone else?
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Vermont_Lymie
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posted
DeLong:
(notes from the middle of her talk)
Clinical improvement (significant) on fatigue in Krupp study.
IDSA criticized these findings based on possible entry criteria; loss to follow-up.
She is analyzing the IDSA critique, and showing why it is a bogus critique.
Goal of an intention to treat analysis is to obtain an estimate --
Such inconsistencies are EXPECTED:
Loss to follow-up did not affect the trial findings on fatigue, despite the IDSA claims that they did.
Problems with masking: using their published numbers, we could see that there was NO quantitative evidence of masking.
Krupp made a mistake on this point, as did the IDSA critique.
Prior work by Krupp and colleagues showed that a 25% improvement forces Lyme patients to perform better than healthy controls -- so this does not prove, as the IDSA claims, that this treatment is ineffective!
(My note -- she totally rocks! Will the IDSA ignore her evidence too? Can they continue to get away with their lying?)
Now discussing the Klempner study.
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sometimesdilly
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posted
Klempner study- FLAWED.
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sometimesdilly
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posted
vermont- you rock getting that level of detail straight, and so quickly!
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sometimesdilly
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posted
Klempner nailed on statistical flaws
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Tincup
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posted
Way to go Allison...
Allison Delong, MS, ILADS & The Center for Statistical Sciences, Brown University, Providence, RI
Vermont_Lymie
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posted
The IDSA better study DeLong's testimony well, or I hope they will be challenged in court.
She is going point by point through the IDSA's "strong evidence"
Klempner -- inefficient, probably biased study:
* Inefficient: Omitting 30 and 90-day follow-up in analysis. * Biased: baseline scores differ by arm; inadequate assessment of patients lost to follow-up *Had unsatisfying measure of treatment effect: - No measure of mean changes on the scale of the SF-36 - Categorized outcomes difficult to interpret clinically.
(My note: how did the IDSA accept such a sloppy study as "strong evidence"?? Bias indeed!)
Trial designed with sample size too small -- inadequate power that cannot show relevant treatment effects. So such effects would not be shown to be statistically significant.
(In other words --- study was designed to fail!)
Terminating a trial for futility (as Klempner study was) does not prove that the treatment was ineffective.
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Abxnomore
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posted
agreed....she'll do that.
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sometimesdilly
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posted
logical flaws result from statistical flaws
"terminating a trial for futility does not show a treatment was ineffective"
PERFECT CONCLUSION
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posted
Wow. Thanks so much for your analysis, folks!
I cannot follow most of what they're saying due to my cognitive issues. How ironic, right?!
Your translations/analyses are much appreciated!
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AliG
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posted
She kicked Klempner's butt!
-------------------- 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. Posts: 4881 | From Middlesex County, NJ | Registered: Jul 2006
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blaze
Unregistered
posted
Could someone post a 'summation' of this when it is all over? The media player on my computer is messed up, so I can't watch this.
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Tincup
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posted
Vermont.. THANK YOU ....
I will need those notes for press releases.
I can't listen and copy as fast... so I am depending on you!
sometimesdilly
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posted
i can't wait to see if any of the panel is going to challenge her data. i doubt it somehow....
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AliG
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posted
Is it me or does she sound like she's holding back tears?
-------------------- 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. Posts: 4881 | From Middlesex County, NJ | Registered: Jul 2006
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Vermont_Lymie
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posted
Thanks Tincup, you are welcome!
I am a fast typer, but may have to leave; fortunately Dilly is taking such great notes!
DeLong is my new hero, makes me want to study statistics... she rocks.
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Tincup
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Pinelady
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posted
She is very nervous and passionate. But she is adamant. So they will listen.
-------------------- 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 Posts: 5850 | From Kentucky | Registered: Dec 2008
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seekhelp
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posted
I can't even get my PCP to read 10-20 pages of test results. Can the IDSA panel follow along with this stuff?
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sometimesdilly
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posted
she sounds nervous. she feels strongly about making her points clear.
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sometimesdilly
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posted
way to go. she's entirely prepared for question of how guidelines should be changed
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sometimesdilly
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posted
um. just say yes, study the raw data. why not say yes?
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Pinelady
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posted
Now she is perfect.
-------------------- 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 Posts: 5850 | From Kentucky | Registered: Dec 2008
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sometimesdilly
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posted
any other fast typist here- vermont, don't go!!!!
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sometimesdilly
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posted
medoff- why are you doing this review of studies. do you plan to publish?
she says- yes, for docs to access to help them assess tx approaches. she suggests it gets published in ID (heh) bingo
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Tincup
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sometimesdilly
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posted
says only IV's, one therapy, is in these studies, and next to nothing of studies has been followed up.
TOO LIMITED
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Vermont_Lymie
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posted
Alison DL on the Klempner study:
Trial was underpowered to detect clinically meaningful effects, and unable to detect clinically meaningful effects
Alison: Designing a trial in this way ``is not reasonable.'' These findings have little value in shaping the IDSA guidelines.
Q: How would you change the guidelines?
ADL: Evidence against retreatment does not exist. Both studies have findings that indicate a benefit from retreatment - for fatigue and extreme pain.
Both studies were small - more research is needed.
(She is awesome!!)
Dr. Lantos: most of your critique is focused on the treatment of raw data rather than the design of studies themselves. Do you think there should be an independent review of raw data?
ADL: Yes, Krupp and Fallon did a good job of analyzing their data;
I find intriguing in the Klempner study: the seronegative patients: at day 180, we could see (looking at results) we really see that there seems to be some effect going on here; we see this earlier too. An appropriate stastical analysis could better see what is going on here.
It would be a beautiful thing if these data (klempner) could become available. How much of this group was comprised of those who dropped out?
In the placebo group, we see some people who improved. That is an artifact of the instrument. Does not mean that their mean values improved.
An analysis of means by the group would be a great thing.
Follow-up question on treatment of klempner data:
ADL: There was an interaction between baseline scores and treatment effect:
At a minimum, these data could be used for data mining, to come up with hypotheses to test. Whoever uses these data should sit with researchers
Q: Curious as to why you are doing these studies? (My note - what a stupid question, who is this guy?) ANS: A publication is in the works; the Klempner study is quoted by many, and a critique should be of interest to many.
ADL: Sample size (in studies) was rarely of the size needed to document adverse events.
But so many treatments have not been studied in the IDSA ``evidence'' of these 3 studies; all of these were IV therapy; and that is all that you can say.
Limitation in what was looked at. We don't even know if these groups returned to their pre-morbid health. We need to know so much more!!
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sometimesdilly
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posted
EEK TURN OFF MIKES, GUYS!! WE ARE HEARING EVERYTHING
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seekhelp
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posted
You're actually there at the hearing Tincup?
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-------------------- worrying about tomorrow takes its strength away from today Posts: 970 | From Point PLeasant , NJ | Registered: Jan 2008
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sometimesdilly
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posted
are we allowed to tape record from this transmission?
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Melanie Reber
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posted
Nice discussion. My notes thus far:
Tina did an amazing job with her testimony! Beautifully stated; articulate and heartfelt.
Questions from the panel included: How much contact has she had with insurance companies? What is her role in fundraising? What is her experience with medical appeals process?
Lorraine explained her role in the LD community (CALDA) and her medical history. (Nice PowerPoint to underline her points... including personal SPECT scans for evidence.) She also coalesced the information from the recent survey and explained the underlying disputes from the LD community re: the Hearing itself, the IDSA guidelines as they are and she compared the restrictions in treating LD with those guidelines to other disease guidelines. Very much the 'opening statement' format. (she is an attorney) Nice. Both Tina and Lorraine are asking for 'Informed Consent' as standard procedure.
Questions from the panel included: How would you revise the guidelines? What do you mean by IDSA guidelines being 'enforced'?
Dr. Cameron, current Pres of ILADS, spoke to denial of patient treatment, limited clinical trials re: CLD (chronic LD), insufficient lab testing and the basic role of guideline purposes. He also spoke to treatment delay, short term treatment failures and poor follow-up on patient conditions. Cameron dissected the criteria for IDSA evidence 'grading schemes' being used in the current guidelines and how they are limited... as compared to standard grading scales for other clinical trials and studies. He also touched on patient costs, both individual and collective, individual patient responses to treatment, co-infections and co-morbidity. (other diseases) Very well thought out and presented. (of course)
Questions from the panel included: What is your scope of medical practice? What do you think the guidelines should include? Do you find the guidelines useful as is? What is your opinion on the specific troubles with LD studies thus far? What would be your ultimate goal of this hearing re: outcome of guidelines? Will you be more specific on evidence grade criteria changes suggested?
Mr. Baker (ALDF) described Bb in particular and 'Chronic' LD specifically. His testimony rehashed the age-old dogma of no evidence supporting a 'Chronic' condition. (sorry, that sounds a tad biased) Baker went over the patient criteria for these 4 NIH funded trails on 'Chronic Lyme' and declared that perhaps these patients never had LD to begin with based on testing. He then speculated on the harm that may be caused with long term ABX usage. Placebo effects, symptom control with other treatment options, cross reactions, auto-immune responses and bogus 'alleged' IDSA conflict of interest charges were all discussed.
Questions from the panel included: Will you clarify the patient disease criteria used for trial enrollment? Please explain statement of 'some patients were excluded from the study may have had chronic Lyme'? Are you aware of studies applying for NIH funding who do believe in Chronic Lyme? What is your background in research? Explain criticisms to studies with regard to ABX? Are there sub-populations of patients who will benefit with long term ABX use?
Dr Luft explained his history with LD studies and patient care. He touched on Borellia persistence, undefined characteristics and treatment failures. Luft distinguished early phases and late phases of the disease state along with objective vs. subjective symptoms... and how that relates to treatment. Comparison of 2 trails ensued (human and animal models), looking at symptoms presented, meds used (Azithromycine vs. Amoxicillin) and serology tested. The patient responses were discussed. The infamous mouse persistence study was mentioned... then he began explaining the second study which tested efficacy of Tigecycline vs Ceftriaxone on the mouse model. Persistence was found even after ABX treatment although antibody levels decreased.
Questions from the panel included: no time for questions
Bio statistician Dr Delong with Brown U was next, presenting findings from trials that do not match current guidelines... specifically addressing recommendations of not retreating. She also looked at the 'grading recommendations' of current guidelines and spoke to the problems and their objections with them. She went over reviews of the studies and restated findings more accurately comparing the results using statistical analysis. Her opinion is that these studies were inadequate and findings were biased. Excellent points raised re: currently published studies.
Questions from the panel included: How would you suggest guidelines be changed? Do you think further study of raw data from these trials would be of benefit? Clarify your data... issues with how it was derived or how it was interpreted? Curious as to why you are doing these statistical analyses? Will you publish findings? Did you analyze adverse effects or events?
Break for 5 minutes...
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Tincup
Honored Contributor (10K+ posts)
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posted
Just called Pat to see how she is doing today.
I know she'll appreciate that.
Next up...
Barbara Johnson, PhD, Centers for Disease Control and Prevention, Fort Collins, CO
posted
i am wondering how many ppl are watching this live
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sometimesdilly
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posted
great summary, melanie!
it feels incredible to be watching this with you all, especially those who have been working tirelessly under constant assault for decades to get us as far as this day, whatever comes next.
THANK YOU!!!
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posted
so glad I have this site to be at today while listening to this...
mtree
TC are you there???
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Melanie Reber
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posted
I've not had time to read all the comments but will after the break, if time. Sorry... mymulti-tasking skills are a bit limited and must concentrate on only one thing... Posts: 7052 | From Colorado | Registered: Mar 2003
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sometimesdilly
Frequent Contributor (1K+ posts)
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posted
are you, wrotek?
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posted
Well done Allison! Agreed, her voice was somewhat shaky (and her can blame her...it has to be intimidating to speak to such a bias group as this), but her information presented was solid and spot on. Again, thank you Allison for all your phenomenal work!
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Melanie Reber
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Member # 3707
posted
darnit my feed just went down?
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sometimesdilly
Frequent Contributor (1K+ posts)
Member # 9982
posted
can't hear transmission- minutes gap
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AliG
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Member # 9734
posted
Aggggh, I've lost feed!!!!
-------------------- 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. Posts: 4881 | From Middlesex County, NJ | Registered: Jul 2006
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bettyg
Unregistered
posted
I have been very impressed so far. Missed 5-10 minutes w/ pc problems.
Tina, great job; it was your beginnging that i missed. Your voice was well controlled. You showed STRONG DETERMINATION and grit to overcome what you have to date.
You represented us well; well done my arizona friend.
Lorraine, what a blessing you are! Slides have helped us hear/read better.
Dr. Cameron; well done! Good slides too; next time please use ARIAL or VERDANA for those of us that can NOT read timesnewroman font; huge thanks
Baker lived up to his reputation!
I have enjoyed 2-3 comments by saying SHALL WE SCRAP THE ENTIRE THING AND START OVER?
Ken stated alot of time was put into it and he felt 3 areas should be looked into and they would know these when reading over idsa guidelines.
Both presenters said NO, just redo certain areas.
Dr. B, thanks for joining us!! THANK YOU for all the work you have done all these years on behalf of ALL lyme and co-infection patients!! YOU TRULY ARE A GEM IN THE ROUGH.
sometimesdilly
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posted
kicked off.
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Vermont_Lymie
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Member # 9780
posted
Thanks Dilly: OK, Medoff the guy who asked the incredibly stupid question of Dr. DeLong: why is she doing these studies, and does she plan to publish?
No wonder he asked; I guess he does not want it revealed that the emperor has no clothes!
Gee, why would anyone want to verify, analyze or critique the IDSA's evidence base? Their guidelines have only harmed untold numbers of people...
Gerald Medoff ISDA New Panelists 2009 Lyme Disease Guidelines *IDSA is honored to present Dr. Medoff with a 2008 Mentor Award. *NIAID Chairman AIDS Research Advisory Committee *Executive Board Member AIDS Clinical Trials Unit *NIH - 30 years of NIH Funding and basic and clinical research *Fellow of the Infectious Diseases Society of America. *Served on a Research Advisory Board for the National Institute of Allergy and Infectious *Diseases along with the CDC *Sited as a conflict of interest for his IOM input on vaccines as a cause autism in children.
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Melanie Reber
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posted
it figures...
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AliG
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posted
HELP!!!!!!!
I've got nothing at all!
-------------------- 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. Posts: 4881 | From Middlesex County, NJ | Registered: Jul 2006
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northstar
Frequent Contributor (1K+ posts)
Member # 7911
posted
I have no sound or pic either, suddenly. I dont get how the cdc person can support using epidemiological for non-em cases, when the cdc states it is a clinical diagnosis. contradictory.
N.
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Tincup
Honored Contributor (10K+ posts)
Member # 5829
posted
Just heard from folks in CT and CA... they are down too.
posted
I know they took a five minute break-after that-just audio-then nothing??
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AliG
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Member # 9734
posted
It's back
-------------------- 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. Posts: 4881 | From Middlesex County, NJ | Registered: Jul 2006
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northstar
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posted
system crash with the cdc folks checking in? Loved the statistician...talk about H bombs on the one study that is the foundation of idsa guidelines.
I had to refresh with the go to url re-entered. working now.
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Vermont_Lymie
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posted
I have no sound or picture; gee, sounds like we are ALL cut-off.
What a surprise?
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