Survey: FDA Proposed Regulation of Lyme Tests

General or non-medical topics with information and discussion related to Lyme disease and other tick-borne diseases.
nnecker
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Re: Survey: FDA Proposed Regulation of Lyme Tests

Post by nnecker » Thu 30 Oct 2014 15:09

All this Barbra Johnson bashing.In her Sapi culture study she states:

"Independent verification is particularly critical
when claims are at odds with a large body of other scientific work and when they may trigger
unnecessary antibiotic treatment of patients. We caution clinicians and patients to WAIT FOR
INDEPENDENT VERIFICATION BY SCIENTIFICALLY SOUND METHODS BEFORE USING THIS CULTURE SERVICE FOR
DIAGNOSTIC PURPOSES."

This is not an unprofessional statement ,this is good advice.

Where are the ALS validation studies that were publicly promised to be delivered in April?And not studies conducted by Billy Bobs Verification Service.(Harvard and Yale would be good choices) ;)

Statement made by member Susank:

"I had the ALS culture test performed Dec 2011.
I think that was before they offered anything other than the basic test.
Probably my specimen was not "sequenced"?
It took almost eleven weeks, but my test was positive.

I am anxiously awaiting news that the test is valid - no contamination etc.
I suspected I had Lyme and thought the culture test proved it.

I go through periods of doubt on the Dx. Now is such a time."

That is what unprofessionalism looks like.
Last edited by nnecker on Thu 30 Oct 2014 16:05, edited 1 time in total.

duncan
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Re: Survey: FDA Proposed Regulation of Lyme Tests

Post by duncan » Thu 30 Oct 2014 15:24

Harvard and Yale. That's funny. :D

duncan
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Re: Survey: FDA Proposed Regulation of Lyme Tests

Post by duncan » Thu 30 Oct 2014 16:30

LHCTom, I just finished reading your "Serious Concerns with CDC Lyme Culture Assessment."

This is very good work. It is as comprehensive as it is well-written. Its logic is clean and you guide the reader effortlessly through to your conclusions.

Send it to the Poughkeepsie Journal. Send it to the NY times. Send it to ILADS, and while you're at it, fire off a copy to our friends at the ALDF and IDSA. Send it to...You get the idea. This should be broadcast to every media outlet that understands English. :)

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ChronicLyme19
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Re: Survey: FDA Proposed Regulation of Lyme Tests

Post by ChronicLyme19 » Thu 30 Oct 2014 16:42

I agree with Duncan, but I'm still afraid your explanation is TLDR, and going to be over the heads of most media and politicians. Poughkeepsie Journal would be a good place to start tho. Mary Beth Pfeiffer has published some good Lyme articles and I know she'll understand it. Maybe she could write something that's a little more media friendly. The politicians up here are in good support of the Lyme community.
Half of what you are taught is incorrect, but which half? What if there's another half missing?

phyfe
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Re: Survey: FDA Proposed Regulation of Lyme Tests

Post by phyfe » Thu 30 Oct 2014 16:58

I agree with Duncan and CL19 both. Tom, why don't you come up with a reader friendly version that can be understood by the press and politicians alike and distribute this openly to all potentially interested parties.

Again, good job!

dlf
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Re: Survey: FDA Proposed Regulation of Lyme Tests

Post by dlf » Thu 30 Oct 2014 18:57

LHCTom,

I have a suggestion. You already know and stated that you were too tired to clean up the paper you have done such good work on. Take a little breather and go back to it! As you re-edit the long scientific version, pull out and copy the most necessary information to put into a shorter second piece that you can then turn into something more understandable to lay people. You really could do a lot with two purpose built pieces. For the second one, talk with a friend who doesn't understand any of this, discuss and explain it to them orally to help them to understand it all. Try taping your conversation, listen to the play-back then figure out how to approach this for an article version that newspapers and magazines could use.

Once you get them both done, think of the immense satisfaction and benefit this could bring!

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LHCTom
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Re: Survey: FDA Proposed Regulation of Lyme Tests

Post by LHCTom » Thu 30 Oct 2014 19:01

I wrote it trying to organize the argument which is subtle and complex. Many think contamination = invalid. I was just trying to organize everything from the Sapi study to Johnson analysis errors but still triggered an MMWR with FDA inclusion , then the Senators jumped in and pushed the LDT rules through based on the MMWR. I knew ALS was working on follow up studies so until it triggered the FDA LDT regulation, so I let it slide hoping they would come out.

I have spoken to two people with microbiology backgrounds and it took almost an hour before they got it but I had to overcome incredible skepticism during the conversations. So I wrote it in hopes it explained what happened to someone willing to listen. Like it or not, the CDC Fort Collins people have big reputations to overcome. I doubt the JCM peer review was much more than a pass. I was planning on sending it to the appropriate people to see what happens but I think it needs some clean up first and a couple versions. A layman's version for an article and one with all the testing and sequence data with links and arguments.

I need to clean up the one I posted first, then trim a version it down like an article. When have the energy. Any comments on English, organization or anything that either doesn't make sense or other diagrams that might help would be nice. I'm hoping some of the more technical people here will try and attack it so I can see flaws. But its been interestingly quiet. I know they are here. Maybe they will forward it to the CDC. :D I'd love to here their response.

Feel free to forward it to the media or anyone.

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The greater the ignorance, the greater the dogmatism.

Attributed to William Osler, 1902

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ChronicLyme19
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Re: Survey: FDA Proposed Regulation of Lyme Tests

Post by ChronicLyme19 » Fri 31 Oct 2014 3:44

LHCTom, sent your post to a family friend who is a biology grad student in genomics and computational biology (also has several years work experience so he's not a complete n00b), so should be able to follow it well.

Didn't really give him much background, but these are his initial comments.
I don't know anything about the history of this test, but the post seems pretty pre-disposed to a certain viewpoint. Some of the logic also seems backwards to me.

For example, nested PCR is a very sensitive method (the signal is exponential to the input) so it makes sense that contamination would show up in that experiment even if it was missed by other techniques. It's not a good idea to use negative results from less sensitive experiments as evidence against positive results from more sensitive experiments (which the author does).

And just in general, the argument seems to be "The experiment was contaminated, but not enough to make a difference" which is not really a great position to start from. I'm personally kind of a validation nut - my boss even gets on me sometimes for talking too much about validation in meetings - so take it with a grain of salt. But, before ramping up a clinical test, I'd want to see it test in more than one paper and by more than one lab.
The solution is get bulletproof evidence, not vilify the regulator.
My response to him was, if the CDC bashes this so much, then other labs might not want to try replicating it because it had a bad rap as not worth while. So the CDC does need to be called out. But yes, I think everyone agrees it'd be nice if they replicate the study with better controls and republish. In the meantime it's good to know there is good development going on.
Half of what you are taught is incorrect, but which half? What if there's another half missing?

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LHCTom
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Re: Survey: FDA Proposed Regulation of Lyme Tests

Post by LHCTom » Fri 31 Oct 2014 5:24

All this Barbra Johnson bashing.In her Sapi culture study she states:
Going carefully through the serious errors in an incomplete study that make sense is hardlh bashing. Its a serious critique of a very questionable study. You have a strange definition of "bashing".

"Independent verification is particularly critical
when claims are at odds with a large body of other scientific work and when they may trigger
unnecessary antibiotic treatment of patients. We caution clinicians and patients to WAIT FOR
INDEPENDENT VERIFICATION BY SCIENTIFICALLY SOUND METHODS BEFORE USING THIS CULTURE SERVICE FOR
DIAGNOSTIC PURPOSES."
Its good advice when its founded on good science. How many people will lose their quality of life waiting. The number of problems caused by reasonable antibiotic use is minimal. The CDC like to cite the 3 cases of IV infections in a population where over 50,000 people die in auto accidents per year. The problems with antibiotics comes about 10000 in line when compared with other causes of death. Its a minor problem in the big picture that is grossly overstated. The real reason is they fear superbugs and are programmed to minimize Abx use for anything. When based on bad science, it can harm patients who need treatment. The CDC study did not use sound scientific principles in their study and its conclusions mislead many doctors. That's very bad science.
This is not an unprofessional statement ,this is good advice.
As a generalization its sensible but in the context of the hand picking the evidence that can lead to harm is disgraceful.
Where are the ALS validation studies that were publicly promised to be delivered in April?And not studies conducted by Billy Bobs Verification Service.(Harvard and Yale would be good choices) ;)
It takes a lot of time to complete a study. If you haven't figured that out, maybe you need to loo at how long quality careful studies typically take. You cannot do a study like this overnight. Its natural for someone like ALS under attack to underestimate. Look at how may crazy things have been said on the ebola crisis that turn out to take forever or are plain wrong from people like the CDC chief Freidman who is acting under pressure. Harvard and Yale have far too large Egos to involve themselves with Sapi and ALS because they think they know it all and the have so many Billions in endowments they can't and wouldn't rush a study if it compromised a study. Use your brain.

Statement made by member Susank:
"I had the ALS culture test performed Dec 2011.
I think that was before they offered anything other than the basic test.
Probably my specimen was not "sequenced"?
It took almost eleven weeks, but my test was positive.
The sequencing option was only offered for a while and most people wouldn't know hat to do with it. What does this have to do with anything. Anybody who wants a solid diagnosis will use redundant testing using different modes so the evidence can be compared because there are no ideal test. Try multiple good labs with both the C6 ELISA, WB and maybe the culture a few times and weigh the evidence. No other way will give you a simple 100% answer. Its not possible.
I am anxiously awaiting news that the test is valid - no contamination etc.
I suspected I had Lyme and thought the culture test proved it.
So far the evidence looks promising on the culture but until they complete follow up studies without any problems, "looks promising" is the best you will get. By the way, the same is true of the other tests and NONE will show an active infection reliability.

It may have but the CDC 2 tiered test is just as problematic. I have not had one test that matched and have used 5 labs. Not one was the same. Except the C6 where I had 3 almost identical results from 3 labs but the CDC is dragging their feet making it part of their algorithm. Go look at Google patents and search on Lyme diagnostics and you will see there are dozens of tests patented by the IDSA gang and with 2 exceptions, the C6 and Pep10 were able to afford the FDA approval cost and delay which can only be afforded by deep pockets. So the bet test doesn't get FDA approved, the ones with big bucks that must be based on the B31 strain and are compared to the 2 tiered test. That's a real sensible way to decide what tests are effective - money and connections...
I go through periods of doubt on the Dx. Now is such a time."
Join the club. Its more than a Dx. Its whether its active NOW. If you are positive due to a successful treatment 5 years ago, then maybe returning to a differential diagnosis makes sense. There is only one test that can identify an active infection. The culture. If you can grow spirochetes that were in your blood, you are infected now. The cost of sequencing is coming way down and a culture with sequencing is the ONLY way to tell you are currently infected and ID the strain. No PCR test can do that no matter how sensitive. Even RNA PCR cannot due to sensitivity.. So think about it. Why are the CDC and NIH not putting effort into a relatively low cost culture technique given it was last improved in the 90's. Don't you think enough has been learned about unculturability or culture difficulty due to low spirochete count per unit blood in the last 20 years given microbiology has advanced a few 100 percent in that time. Its about beliefs, skepticism and professional pressures. If you can't understand that - try a brain reboot.

And there are many improvements possible with the culture:
1) more blood - you can donate a pint but a typical culture is 9ml.
2) attractants
3) improved media
4) blood filtering
5) synthetic xenodiagnosis-like strategy
6) etc...

They are still using the techniques developed in the 80's and 90's. Sapi was the first to recently use some imagination - if not good enough its still the BEST strategy for showing persistence. PERIOD!

That is what unprofessionalism looks like.
Hardly. :bonk:
The greater the ignorance, the greater the dogmatism.

Attributed to William Osler, 1902

nnecker
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Re: Survey: FDA Proposed Regulation of Lyme Tests

Post by nnecker » Fri 31 Oct 2014 10:46

Chroniclyme19's friend said(about LHCTom's CDC rant):

"....the post seems pretty pre-disposed to a certain viewpoint. Some of the logic also seems backwards to me.....

And just in general, the argument seems to be "The experiment was contaminated, but not enough to make a difference" which is not really a great position to start from. I'm personally kind of a validation nut - my boss even gets on me sometimes for talking too much about validation in meetings - so take it with a grain of salt. But, before ramping up a clinical test, I'd want to see it test in more than one paper and by more than one lab.
The solution is get bulletproof evidence, not vilify the regulator."

Your friend sounds like a really smart guy.Like a chip off of Barbra Johnson's block. :lol:
Last edited by nnecker on Fri 31 Oct 2014 15:18, edited 1 time in total.

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