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.
velvetmagnetta
Posts: 469
Joined: Sun 23 Feb 2014 22:47

Re: Survey: FDA Proposed Regulation of Lyme Tests

Post by velvetmagnetta » Tue 11 Nov 2014 7:35

Hi nnecker -

Sorry for sounding so harsh. I do greatly appreciate your efforts to keep the information out there on the net about Lyme on the straight and narrow. The only way we're going to solve these considerable problems of post-treatment Lyme that people are having is if we keep the research and the dialogue about the research honest.

I thought Duncan was extremely rude to you and there is just no excuse for that kind of behavior. I was going to say as much, but the anger about the FDA and the CDC dragging their feet over verifying Sapi's culture test and/or creating a culture test of their own just overtook me.

I'm sorry I didn't say anything. Well, I have now. But the issue is still a burning one - where is our culture test to put this absurd persistence argument to rest already? I'm tired of it. It's holding all progress up. I don't believe Lyme persists. I believe antibiotics are very good and quick about killing it off and I want to move on from this persistence rut and find out what on God's Green Earth is really wrong with all of us!

Even if there are some remaining persisters (even Dial soap can only claim that it kills 99% of all bacteria!) they are most likely either dormant, attenuated, or both and either way, in that state, they are not interacting with the immune system, so they can't possibly be the source of all our post-treatment misery!

Dr. Sapi's culture recipe is not a trade secret as Henry claims. She submitted a paper to the public domain for all to see exactly what her culture base is made of - including the all-important ratios!

Here, take a look:

http://www.medsci.org/v10p0362.htm

Look under the section "Culture Protocol". Anyone who wishes may repeat this experiment. That means you, Henry, hv808ct, FDA, IDSA, and CDC.
Culture protocol

Blood samples (~30 ml /patient) were collected in the following tubes: 9.0 ml peripheral blood in a 15.0 ml polypropylene Falcon tube containing 5 ml BSK-H, two samples consisting of 9.0 ml peripheral blood in 10.0 ml red top (no additive) Vacutainer tube, or Vacutainer tubes containing EDTA (purple top).

Blood samples were transported to the laboratory overnight at room temperature and upon receipt they were allowed to sit undisturbed for several hours at room temperature to allow serum separation.

The serum was divided into eight starter cultures for each clinical sample and mixed with modified BSK-H media (mBSK-H) - four in the standard 15 ml glass tube (13 ml final volume) and four in the small 2ml cryo tubes (1.8 ml final volume) as summarized in Table 2.

Cultures were incubated at 34o C with 5% CO2 and 100% humidity. The lids of all culture tubes were closed loosely to allow limited gas exchange between the culture medium and the environment. Starter cultures were harvested after 6 days and used for either immunocytochemical studies or to seed a long-term culture.

Long-term cultures were established by combining and directly transferring cells and media from culture tubes to a Coplin jar with an additional 15 ml mBSK-H media (total volume of 34 ml), a 5 μg rifampicin disc (BD Scientific) and 2 collagen coated slides (Rat-tail type I; BD Scientific) and maintained through 16 weeks at 34oC with 5% CO2 and 100% humidity.

After 8 weeks, one slide was checked under dark field microscopy and used for polyclonal anti-Borrelia antibody detection analysis. If the fluorescent antibody result was negative at 8 weeks of culture, another collagen coated slide was placed in the Coplin jar and half of the culture media (~17 ml) was replaced with fresh mBSK-H medium and the culture was incubated for an additional 8 weeks.

And there are even more details in the paper. Check under "Optimization of BSK-H media" and then a little further down, "Establishment of Long-term culture environment".

So, come on! Quit yer bitchin' and do something already!

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ChronicLyme19
Posts: 564
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Location: NY, USA

Re: Survey: FDA Proposed Regulation of Lyme Tests

Post by ChronicLyme19 » Tue 11 Nov 2014 14:16

velvetmagnetta wrote:I don't believe Lyme persists.
I have to respectfully disagree. I strongly believe there are those of us in which it continues to persist despite antibiotic treatment. It may not be the case for you, and it may not be the case for 90% plus of people who get Lyme, but there is a small subset of people in which we can't kick the infection and antibiotics still help. There are a myriad of reasons why Lyme could persist:

Antibiotic resistant strain (just like MRSA, there could be antibiotic resistant strains)
Biofilms
Persister cells
Genetic susceptibility (MTHFR for example)
Immune Deficiencies
Coinfections
Sub-optimal abx absorption
Lyme's suppression and modulation of the immune system
And a myriad of underlying other conditions

I highly encourage people to find the GRAY, and stop thinking in black and white. Black and white thinking doesn't do us any good. Why does everyone have to fall under the same group? Why can't we have groups of people that have different stories and different responses to treatment: a group of people who clear the infection easily with abx (like the ones my LLMD talked about who have strong IgG response), a group of people like yourself that have finally beaten the infection but have lasting nerve damage, a group of people like me in which antibiotics still make a difference (perhaps this group has some problem with IgGs), and group x, y and z in which they have some other possibility.
velvetmagnetta wrote: I believe antibiotics are very good and quick about killing it off and I want to move on from this persistence rut and find out what on God's Green Earth is really wrong with all of us!
If abx kill off all lyme so easily, why did John's Hopkins go an do a study on abx to try to kill off persisters? Did they just not dose the bacteria with enough abx in the first place? It would seem unlikely that such an institution would put such an easy flaw in their study. I would expect that they would have tried very hard to kill the lyme with abx before doing a study on persisters.

TLDR; we need to have a test with 100% sensitivity to end this debate once and for all. There are gray areas in which Lyme persists.
Half of what you are taught is incorrect, but which half? What if there's another half missing?

duncan
Posts: 1370
Joined: Wed 5 Sep 2012 18:48

Re: Survey: FDA Proposed Regulation of Lyme Tests

Post by duncan » Wed 12 Nov 2014 16:43

velvetmagnetta, you write above about improving our knowledge of post-treatment Lyme through honest research and dialogue.

I agree with you. I think they should also be doing the same for Late Stage Lyme - they are not - and for NB - they are not.

So, with the idea that I subscribe to that agencies such as the NIH have dropped the ball the past few years for honest research and dialogue regarding Late Stage Lyme and NeuroBorreliosis, what makes you think they are directly interested or directly involved in that breed of meaningful exploration into PTLDS? Into biomarkers for the syndrome concept they so thoughtfully created, and in so doing, virtually eliminated efforts into Late Stage manifestations other than arthritis. The only major study into that subject (launched back in the late '90's) run by the NIH is not really looking at immune biomarkers these days, or so I am led to believe. So, how are they characterizing post-treatment patients? If the markers used for Lyme do not apply for PTLDS, what markers are they using? If they are not using any yet, what areas are they looking at or for? Where is the honest research and dialogue into that area you are concerned about as it pertains to the NIH in the U.S.?

This is a serious question and does in fact speak to honest dialogue and research. Integrity, too. And care for patients. And as I mentioned earlier, applies equally to Late Stage Lyme and NB.

Henry
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Joined: Thu 10 Nov 2011 18:49

Re: Survey: FDA Proposed Regulation of Lyme Tests

Post by Henry » Wed 12 Nov 2014 19:52

Duncan: For someone who talks about honesty and integrity, you seem to have those qualities in short supply. You make false and wild accusations -- and assume all sorts of unsubstantiated motives-- without even bothering to inquire what types of research the NIH is funding. Such information is publicly available. Although the figures for 2014 are not yet available, here's what was funded in 20013:

http://report.nih.gov/categorical_spend ... %20Disease

You don't know what you are talking about and have no credibility. Also, you don't have any idea what new grant applications have been submitted and whether any of them will be funded. In short, you have no idea what investigators in the field are trying to do. Politics have nothing to do with it. It's more a reflection of your ignorance.
Last edited by Henry on Wed 12 Nov 2014 20:10, edited 2 times in total.

nnecker
Posts: 215
Joined: Wed 19 Dec 2012 22:57

Re: Survey: FDA Proposed Regulation of Lyme Tests

Post by nnecker » Wed 12 Nov 2014 20:02

Here comes the dogma and politics rant.On your marks.....get set.....go!!!

duncan
Posts: 1370
Joined: Wed 5 Sep 2012 18:48

Re: Survey: FDA Proposed Regulation of Lyme Tests

Post by duncan » Wed 12 Nov 2014 20:15

Henry, you silly boy. I've missed you. It's good to have you back.

Now, look at the list of studies your link leads to. LOOK at them this time. Closely. Number does not equate to quality, wouldn't you agree? Or relevance for that matter...

Other than the Tulane studies - in monkeys - representing NB, what else do you see? How many relate to non-acute issues?

Also, my point is, what is the NIH specifically involved with, not just peripherally, through grants. Smoke and mirrors, Henry.

And please be nice. :)

phyfe
Posts: 167
Joined: Sat 15 Sep 2012 19:28

Re: Survey: FDA Proposed Regulation of Lyme Tests

Post by phyfe » Wed 12 Nov 2014 20:21

velvetmagnetta wrote:Hi nnecker -

Sorry for sounding so harsh. I do greatly appreciate your efforts to keep the information out there on the net about Lyme on the straight and narrow. The only way we're going to solve these considerable problems of post-treatment Lyme that people are having is if we keep the research and the dialogue about the research honest.

I thought Duncan was extremely rude to you and there is just no excuse for that kind of behavior. I was going to say as much, but the anger about the FDA and the CDC dragging their feet over verifying Sapi's culture test and/or creating a culture test of their own just overtook me.
Duncan is one of the least rude people on this forum and the fact that you say that is extremely unfair. nnecker has nothing valid to say as a general rule and only comes out to bash patients and help henry with his rants...he's not worth your time Velvet.

phyfe
Posts: 167
Joined: Sat 15 Sep 2012 19:28

Re: Survey: FDA Proposed Regulation of Lyme Tests

Post by phyfe » Wed 12 Nov 2014 20:38

Henry wrote:Duncan: For someone who talks about honesty and integrity, you seem to have those qualities in short supply. You make false and wild accusations -- and assume all sorts of unsubstantiated motives-- without even bothering to inquire what types of research the NIH is funding. Such information is publicly available. Although the figures for 2014 are not yet available, here's what was funded in 20013:

http://report.nih.gov/categorical_spend ... %20Disease

You don't know what you are talking about and have no credibility. Also, you don't have any idea what new grant applications have been submitted and whether any of them will be funded. In short, you have no idea what investigators in the field are trying to do. Politics have nothing to do with it. It's more a reflection of your ignorance.
Henry, I can't believe you're referencing these piddling little research grants and acting like they mean anything. They spend millions every year on studying male-pattern baldness...millions! As far as honesty and integrity is concerned, you don't have any at all. You're not even a patient, you are so lacking in self-esteem that you have to come on this forum and bash real patients with real problems. Go get a life!

Henry
Posts: 1108
Joined: Thu 10 Nov 2011 18:49

Re: Survey: FDA Proposed Regulation of Lyme Tests

Post by Henry » Wed 12 Nov 2014 20:40

Duncan: Your ignorance of the NIH grant awards process is just appalling. Right now, the NIH is funding only the top 8% of all submitted and rigorously reviewed (scored) grant applications. That's the top 8%, Duncan, not the bottom 8%.
What really seems to bother you is that what the NIH is funding is not consistent with what you think is important and of high priority. And, just what are your credentials to qualify you to make judgements in that regard? How much research on Lyme disease have you actually done? Have you ever submitted a grant application focused what you consider to be the important issues? Perhaps many of your ideas them have been pursued by others and have been addressed in previous published studies that you choose to ignore because the results conflict with your biased ideas -- or are politically motivated. Talk is cheap. Show me what you can do.

duncan
Posts: 1370
Joined: Wed 5 Sep 2012 18:48

Re: Survey: FDA Proposed Regulation of Lyme Tests

Post by duncan » Wed 12 Nov 2014 20:54

Henry, my qualifications are inscribed in my lab results. They are written in the disease I live. As opposed to those I observe in an obtuse researcher/clinician with a bias to satisfy, and three kids (or whatever) to put through college. I suggest you place your accounting sheet to the side, and look to the merits of helping those inflicted with Bb and other TBDs - before you miss the boat for humanity.

Talk is not cheap when royalties are on the line, is it? Or liabilities are entertained.
Last edited by duncan on Wed 12 Nov 2014 20:59, edited 1 time in total.

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