Why the Government is Suppressing the Lyme Disease Epidemic

Medical topics with questions, information and discussion related to Lyme disease and other tick-borne diseases.
hv808ct
Posts: 256
Joined: Wed 30 Jul 2008 4:11

Re: Why the Government is Suppressing the Lyme Disease Epide

Post by hv808ct » Sat 10 Jan 2015 16:50

Re: Why the Government is Suppressing the Lyme Disease Epide
Post by duncan » Sat 10 Jan 2015 15:07

Yes, Henry, my allusion to patents was just an off-the-cuff reference to the multimillion dollar Lyme diagnostic market ($500 mill or there abouts?).
Why worry about patents when you can rake in serious money with a non-standard, unvalidated in-house assay?


2014 Can You Trust Lyme Disease Tests?
https://necir.creatavist.com/lymediseasetesting

While the CDC has specific guidelines to interpret the results to identify Lyme, some labs interpret them far more liberally. IGeneX Inc., for example, a Palo Alto, Calif. lab that performs more than 20,000 Lyme tests a year, uses different interpretation criteria for the Western Blot. On its website, the lab also offers others, such as a urine test, that is not recommended by the CDC. IGeneX was rejected by New York three times for Lyme tests in the past decade for not having enough documentation to prove the tests worked. The lab did not respond to requests for comment.


Many tests to diagnose Lyme, but no proof they do.
The Boston Globe. By Beth Daley | October 21, 2013

“You need a ton of documentation,’’ time, and money, said Jyotsna S. Shah, vice president of IGeneX Inc., a Palo Alto, Calif., lab that performs more than 25,000 Lyme tests a year for hundreds of dollars each.



NYT, August 23, 2005
Unproved Lyme Disease Tests Prompt Warnings
By DAN HURLEY and MARC SANTORA

Dr. Harris, of IGeneX, estimated that his laboratory tested 50,000 to 75,000 patients each year. (Prices go up to $390 for a battery of tests it recommends.) "These are patients who have been bounced around," he said. "A lot of them were undertreated at some time, and their disease came back."


2014. Lyme Activist Web site.
The cost of a western blot for IGM and IGG antibodies through IGenex is $200 US dollars.
You will pay anywhere from $200 - $500 depending on which tests you order….

2010. Igenex basix WB.... $260.00
Basic Lyme Panel is $260.00 (Western Blot Igm/Igg and Lyme IFA).
We did the #188 and #189 at our LLMD's request for $200.


Each year, IGeneX, Inc. conducts about 20,000-30,000 diagnostic tests for Lyme disease. Since they charge $260-$300 per test, this results in an annual income of $5.2M- $9.0M, quite a tidy sum of money for a test considered to be a “in house” laboratory diagnostic test (LDT) and therefore immune from the rigorous requirements demanded by the FDA for validation of commercially available diagnostic tests. However, it should be noted that IGeneX’s diagnostic tests for Lyme disease have never been validated independently, and make several claims that have never been subjected to rigorous peer review. These have been cited on its website (http://igenex.com/Website), mostly in the section dealing Western blots. They include the following the following:

1. IGeneX, Inc. uses lysates of Borrelia burgdorferi strain 297, instead of Borrelia burgdorferi B31, as the antigen/ligand in its ELISA and Western blots diagnostic tests. They claim this enables one to detected antibodies against antigens that are not present in strain B31, thereby allowing one to detect infections that otherwise would escape detection. However, no data have ever been presented to substantiate such a claim. In fact, examples of the results typically obtained with their Western blots (see their website) reveal the presence of no new antibody specificities, i.e., antibodies that are not also generated in response to the antigens derived from strain B31.
2. For a positive IgG Western blot, the CDC requires the presence of 5 of a possible 10 antigenic bands. By contrast, IGeneX, Inc. requires the presence of only 2 of a possible 6 bands. It includes 2 bands (31kDa and 34kDa) that are not included in the CDC criteria for a positive IgG Western blot, but claimed by IGeneX , Inc. to be associated with recurrent and/or persistent disease; there are no data to substantiate such a claim. Also, there are no data to indicate that the presence of fewer (2) bands on an IgG Western blot results in greater confidence with respect to seropositivity than the 5 bands required by the CDC as part of its criteria. It should be noted that the CDC’s requirement for 5 of 10 possible bands for a positive IgG Western blot is based on hundreds of tests conducted on panels of well-characterized reference specimens.
3. It has been claimed that the presence of some of the higher numbered bands on an IgG Western blot are indicative of late or chronic Lyme disease. No data has ever been presented to substantiate such a claim.
The foregoing comments explain why the tests used by IGeneX, Inc. for the diagnosis of Lyme disease result in a high rate of false positive tests, as well as the unnecessary extended antibiotic therapy to treat an infection that is not present. They underscore the need for IGeneX, Inc. to conform to the more rigorous standards for validation required by the FDA for other commercial diagnostic tests.

Comments to FDA ref Igenex LD testing


And speaking of making money from Lyme disease, there's quite a product list of things for Lyme quacks and activists to hawk to the foolish and gullible.


Released in 2013/2014

Freedom From Lyme Disease by Bryan Rosner - just released in August, 2014
Combatting Biofilms by James Schaller, MD, - just released in April, 2014
Treatment of Chronic Lyme Disease by Burton Waisbren, MD, FACP, FIDSA (book)
Why Can't I Get Better by Dr. Richard Horowitz (book)
Beginner's Guide to Lyme Disease by Dr. Nicola McFadzean (book)
Beyond Lyme Disease by Connie Strasheim (book)
Dr. Richard Horowitz Presentation (DVD)
Lyme Disease in Australia by Dr. Nicola McFadzean (book)
Lyme Disease Co-Infections by Stephen Buhner (book) Dr. Burrascano
+ Lyme Panel 2-DVD Set (DVD set)
The Tick Slayer, by Perry Louis Fields (book)
Lyme Disease in Australia (book)

Released in 2011/2012

Dietrich Klinghardt, MD, PhD, DVD Set (DVD set)
2011 Rife Handbook (book)
Defeat Cancer (book or eBook) Cancer is Curable Now (DVD)
Andrew Cutler, PhD, Audio CD Series (audio CDs)

Released in 2011

Treatment of Chronic Lyme Disease by Burton Waisbren, MD, FACP, FIDSA (book)
Dietrich Klinghardt, MD, PhD, DVD Set (DVD set)
2011 Rife Handbook (book)
Defeat Cancer (book or eBook) Cancer is Curable Now (DVD)
Andrew Cutler, PhD, Audio CD Series (audio CDs)

Released in 2010

Recipes For Repair (book)
The Lyme Diet (book)
Under Our Skin (DVD)
Ending Denial (book)
The Silent Saboteurs (book)
Healing Chronic Illness (book)
Healing Lyme Naturally (book)

Released in 2009

Insights Into Lyme Disease Treatment (book)
The Rife Handbook [Updated Edition] (book)
2009 Babesia Update (book)
The Stealth Killer (book)
Rife's World of Electromedicine (book)
Renegade Patient (book)
Cure Unknown (book)
Evan's Gate (DVD)

Released in 2008

The Lyme-Autism Connection (book)
Bartonella: Diagnosis and Treatment (book)
Cell-Wall Deficient Forms: Stealth Pathogens (book)
2008 Lyme Disease Annual Report (book)
2008 Rife Conference Presentation by Nenah Sylver, Ph.D. (DVD)
The Lyme Disease Solution (book)
The Lyme Disease Survival Guide (book)

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

Re: Why the Government is Suppressing the Lyme Disease Epide

Post by duncan » Sat 10 Jan 2015 16:55

And Henry, all the discussions on my part in this thread have been hypothetical anyways - they do not represent me specifically necessarily. This also holds true to the IgM/IgG bands I mentioned.

As in, those three IgG bands I just mentioned this morning? Or bands 31 or 34 yesterday? They were hypotheticals, Henry.

:bonk:

RitaA
Posts: 2768
Joined: Thu 1 Jul 2010 8:33

Re: Why the Government is Suppressing the Lyme Disease Epide

Post by RitaA » Sat 10 Jan 2015 16:58

Okay, guys. I feel the need to step in for just a second because sarcasm can be difficult to detect online.
duncan wrote:Symptoms? Oh, that's what you want? Symptoms??

We all of us - each and every one - have grotesquely swollen knees and this weird EM rash that never, ever goes away and is in plain sight for everyone to see, always.
Henry wrote:Now, what about your EM rash that doesn't seem to go away despite recommended antibiotic therapy? Although I have never heard of such a thing, I couldn't resist the temptation to contact a physician who has vast experience treating patients with Lyme disease. He told me that in all his many years of experience, he only saw one case of an EM rash that would not go away with antibiotic treatment; upon further examination, it proved to be a pseudo-EM rash.

So, based on what you've told me, I must conclude that you do not have Lyme disease, but some other medical condition that won't improve as long as you are treated as though you have Lyme disease. You've been doing this for how many years? Don't you think it is about time you quit "beating that dead horse" and consider other possibilities? Believe me, I'm trying to help you, Duncan.
duncan wrote::shock:

Henry, are you ok?
Duncan, it's pretty clear to me that Henry took your comment about an EM that never goes away quite literally.

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

Re: Why the Government is Suppressing the Lyme Disease Epide

Post by Henry » Sat 10 Jan 2015 17:09

Your "hypotheticals" have been exposed as illogical and therefore worthless. To take them seriously is an utter waste of time, because they don't correspond with the realities of the situation. I won't waste my time responding to them -- or you. I thought this was to be a serious discussion. But, you just want to play "word games".

In my opinion, your have been revealed as one who is self-diagnosed for Lyme disease and is grasping for whatever information he can find to support his false diagnosis. But, it's your life -- you can do with it what you wish. Take consolation from the fact that there are others like you who frequent this website. Birds of the same feather tend to flock together as they say.

Rita: I don't "buy" your interpretation. If you believe that, how does it help matters and facilitate communication?

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

Re: Why the Government is Suppressing the Lyme Disease Epide

Post by duncan » Sat 10 Jan 2015 17:16

Rita, I doubt it.

Henry, in what way have my hypotheticals been exposed as illogical? You are just stringing words together. I think my logic is pretty sound. :)

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

Re: Why the Government is Suppressing the Lyme Disease Epide

Post by Henry » Sat 10 Jan 2015 17:25

Is this a real statement or a hypothetical? Just read my responses.

RitaA
Posts: 2768
Joined: Thu 1 Jul 2010 8:33

Re: Why the Government is Suppressing the Lyme Disease Epide

Post by RitaA » Sat 10 Jan 2015 17:28

Henry wrote:Rita: I don't "buy" your interpretation. If you believe that, how does it help matters and facilitate communication?
duncan wrote:Rita, I doubt it.
Henry and Duncan,

I was hoping you might both step back for a second and take a deep breath because it sure seems like you are misunderstanding one another.

Then again, I could be completely wrong. If that's the case, what prompted Henry to consult with a physician about an EM that doesn't go away despite antibiotic treatment? I couldn't find anything else in this thread that might explain this.

At least you are united in thinking I'm mistaken in my interpretation. I have no problem admitting I could be wrong.

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

Re: Why the Government is Suppressing the Lyme Disease Epide

Post by duncan » Sat 10 Jan 2015 17:34

Do you like to fish, Henry? I get the sense you do.

My arguments seem sound to me, until you or someone else prove them otherwise.

Rita, if Henry actually consulted someone, I thank him for his concern.

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

Re: Why the Government is Suppressing the Lyme Disease Epide

Post by phyfe » Sat 10 Jan 2015 17:44

Let's clarify one thing right now Henry. Duncan how many doctors have diagnosed you as having Lyme? Of course you don't have to answer, but Henry is being a jerk and needs to be stopped!

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

Re: Why the Government is Suppressing the Lyme Disease Epide

Post by duncan » Sat 10 Jan 2015 17:46

I don't know. Five or six? All via 2T testing.

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