posted
The FDA recently changed their policy regarding Lab Developed Tests. Now a study by Fallon at Columbia will probably give the CDC/FDA ammunition to possibly go after IGeneX.
A comparison of Lyme disease serologic test results from four laboratories in patients with persistent symptoms after antibiotic treatment.
They sent blood samples left over from 2 earlier Lyme PTLS studies at Columbia to 4 different labs to look at differences along with healthy controls. They sent the blood to a University Lab, a Commercial lab and 2 specialty labs MDL and IGeneX.
When using the IGeneX internal criteria as opposed to the CDC criteria, they had a large number of false positives on healthy controls they also sent.
This is not good because it provides the FDA with study data that could be used against IGenex in their new effort to regulate LDTs by Fallon who has traditionally been pro-Lyme patient.
Posts: 53 | From Jupiter | Registered: Aug 2013
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poppy
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posted
How do they know they are false positives? That is the problem I see with this.
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Carol in PA
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posted
"When using the IGeneX internal criteria as opposed to the CDC criteria, they had a large number of false positives on healthy controls they also sent."
Without having read the study, I think it's possible for "healthy" people to have the Lyme bacteria in their bodies. Their immune systems are doing a better job of suppressing it.
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poppy
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posted
A very superficial study that advanced the diagnosis of lyme not at all.
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posted
The important point I was trying to make was the FDA has a new policy mandate to regulate Lyme LDTs. This is a small study but high profile because of the Columbia Tick Borne Research being funded by Lyme Groups and generally has questioned the CDC and IDSA.
IGeneX had a particularly high false positive rate on the 40 healthy controls defined below and a very high number of discordant pairs = 22( mismatches to the University reference lab ) and a 27.5% false positive rate with their criteria.
Yes the study is limited and the controls wree not extensively shown to be truly healty but you can bet the FDA is looking at ALS and IGeneX and gunning for them.
This is a very good reason to write letters and or support petitions against regulation of LDTs.
It goes beyond ALS and IGeneX. If the FDA went after them, it would probably mean they would go after all the non-B31 CDC citeria 2 tiered tests that are not FDA approved
The FDA and CD have misled US Senators who drove this new policy change into effect.
"Control subjects met the following criteria: 1) no history of prior diagnosis or treatment for LD; 2) no history of Lyme-like symptoms or illness (e.g., chronic fatigue syndrome, fibromyalgia, arthritic disorder, peripheral neuropathy); 3) no history of another major neurologic or medical disorder; and 4) lack of residence in or recent exposure to a highly Lyme-endemic area."
Posts: 53 | From Jupiter | Registered: Aug 2013
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posted
The Fallon paper is a disgrace.Dr. Fallon was allowed to set up the institute at Columbia by the authorities because they believed they could manipulat him and use him to serve the Denialist interests - and they were right. He has sold his soul and the Lyme movement should not give him a penny more in funding.
Just his choice of language in the study shows he has fallen in line with the Denialists completely. He refers to the notoriously INSENSITIVE CDC 2 tier testing as "sensitive" and speaks in an insulting, sarcastic way about Igenex that we have seen in the past only from Steerites.
Elena
-------------------- Justice will be ours. Posts: 786 | From UK | Registered: Oct 2007
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Razzle
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posted
Where did the funding for this study come from?
Answering that may tell us why the results were what they were...
-------------------- -Razzle Lyme IgM IGeneX Pos. 18+++, 23-25+, 30++, 31+, 34++, 39 IND, 83-93 IND; IgG IGeneX Neg. 30+, 39 IND; Mayo/CDC Pos. IgM 23+, 39+; IgG Mayo/CDC Neg. band 41+; Bart. (clinical dx; Fry Labs neg. for all coinfections), sx >30 yrs. Posts: 4166 | From WA | Registered: Feb 2011
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posted
My impression of Dr Fallon is he has been very helpful to the Lyme community.
The study was suggested and paid for by the Lyme Research Alliance and the Lyme Disease Association who also have been supportive of good work. He is only he messenger.
Nowhere in the paper does it make any reference to the sensitivity or quality of the CDC 2 tiered test. It just compares 3 labs against the University lab as a reference.
So the numbers reported are relative to an already bad sensitivity. It doesn't say the numbers are actual sensitivity, just relative. So if the real number is 50%, and this says 90% relative, that's actually .5 x .9 =45%.
Dr Fallon has stated many times in many places that the actual sensitivity of the CDC tests is terrible.
Making a comparison is quite different from actual sensitivities based on culture confirmed Lyme. It was actually trying to make the point that the test sucks or is discordant even from lab to lab on top of being bad itself.
The study simply used blood from chronic Lyme patients in earlier studies and compared the results against a University based laboratory and made no claims about real sensitivity or specificity and only relative to the University with a small group of people with blood frozen for years.
I also can't find any sarcastic or insulting language about anyone. The paper is clear its underpowered and has limitations due to the patients and controls from the original studies being small.
The study was funded and arranged by good Lyme organizations and the paper just reported what they found.
My concern is the FDA will misconstrue the results given they are on an LDT witch hunt. Fallon makes it clear its just a comparison and underpowered with significant limitations and only a small comparison. Its just lousy timing.
The problem is with the CDC and FDA. Fallon has been far more helpful than hurtful and had to report what they found since Lyme groups paid for the study.
Posts: 53 | From Jupiter | Registered: Aug 2013
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posted
Elara you wrote: "My impression of Dr Fallon is he has been very helpful to the Lyme community."
Yes, he WAS. In the PAST.
I know that LDA and other US Lyme organisations funded his work. That is why I said they should pull their funding.
For some years, since being offered the highly prestigious directorship of the Columbia Lyme centre, he has been a one-way trajectory towards becoming a puppet of the Denialists.
With this paper, he reaches the "zenith" or rather, the "abyss" of that journey.
Elara you said:
"Nowhere in the paper does it make any reference to the sensitivity or quality of the CDC 2 tiered test. It just compares 3 labs against the University lab as a reference."
Please look at his paper again. In paragraph 3 of the introductory section, Fallon et al write:
"The Centers for Disease Control (CDC)has developed a two-tiered diagnostic algorithm for LD in the United States, consisting of a sensitve Whole Cell sonicate (WCS) Screening Assay -eg ELISA...or IFA...followed by IgG or IgM western blot testing of positive or equivocal samples..."
The Elisa is not, has never been, and likely NEVER WILL BE a "sensitive" assay, and Fallon should know that. He knew that 15 years ago. Why has he suddenly forgotten it?
The misuse of the Elisa to rule out Lyme is directly responsible for thousands of lives destroyed, and probably a hefty number of fatalities too.
Elara you wrote: "It was actually trying to make the point that the test sucks or is discordant even from lab to lab on top of being bad itself. "
No, he is trying to make the (absolute false) point that the C6 Elisa is a good test, and that (equally false) that Igenex lab's in-house criteria is inferior.
He has adopted the language and terminology if the Steerites in all its florid patient-hating offensiveness. Why does he call chronic Lyme "Post-treatment Lyme Sundrome" for a start? That is the Denialists' phrase.
And even the Denialists occasionally pay lip service to the fact that medicine is divided over this issue by occasionally using the phrase "chronic Lyme/PTLS"/ But no, Fallon adopts "PTLS" as if it's a reality.
What is "post-treatment Lyme syndrome?" Nothing but a deliberately misleading phrase coined to muddy the waters and deny treatment to any Lyme patient past the very early stages.
Remember, the patients whose blood was used in this study were all patients who had been proven to have Lyme, had antibiotic treatment, yet continued to have the same symptoms.
If a TB patient is still coughing his lungs away after two weeks antibiotics, do we cut off his abx and re-christen his disease "post-treatment TB syndrome"?
If a teenager's acne does not fully clear up after two weeks' abx, does his doctor stop the treatment and refer him back to the dermatologist, on the grounds that the exact same lesions on his face must be some new rash unrelated to what was there a fortnight prior?
No. so why this absurdity in Lyme?
The attack on Igenex is not "mis-timed" - rather, it was expertly timed by the people who are now pulling Dr F's puppet strings - CDC etc.. Timed to coincide with their attempt to destroy the last remaining hopes of Lyme patients in the US for accurate doagnosis, such as Igenex and the Advanced Laboratory culture test.
The healthy controls only had not be resident in a highly endemic area for Lyme. Who definedwhat is, and what is not a "highly endemic area"? I will bet you anything he used Steerite criteria for that.
also since when is it only possible to be bitten in a **highly** endemic area?
It's logical that many people will be exposed and even if they do not get ill, they will produce antibodies to Borrelia. So the "unacceptably high specificity" Fallon complains about is meaningless.
He also speaks very sneeringly about igenex as a lab "claiming singular" expertise in Lyme.
Elena
-------------------- Justice will be ours. Posts: 786 | From UK | Registered: Oct 2007
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Rumigirl
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posted
This is horrible!!! ANd sadly, I am not all that surprised. I have known for years that Fallon was straddling both sides of the fence, and really was coming down on the IDSA side more and more.
And this after LDA, etc. funded him to open the Center!
He is kowtowing to "the powers that be" to advance, or maintain, his career. I've heard him speak numerous times, not to mention reading his studies. He is not much on our side.
This recent "study" is the final blow. I have seen way too many doctors kowtow to the powers that be, convieniently "forgetting" the truth. I think they even convince themselves that this is right in some cases. Or they just don't care, as long as they save their own behinds.
BTW, I know people who have gone to the Center, hoping that they will get a good work up and diagnoses, but do not. The Center denies that they have Lyme, when it is quite obvious that they do. I do not recommend going there. And they charge thousands of dollars to boot.
[I don't have time right now to go into more detail, as Eight Legs eloquently has).
This infuriates me; he is condemning millions to unending suffering and death---to save his own behind. Preaching to the choir as usual.
[ 09-22-2014, 09:21 PM: Message edited by: Rumigirl ]
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