IDSA has announced an open comment period for their “reassessment” of Lyme disease diagnostic and treatment guidelines. IF you are inclined to engage with criminals and respond to IDSA by April 9, here are some choice words that we have prepared. You could use the long text, or just a short and sweet, “We know what you did at Dearborn, so don’t even think about another shell game with mass spec.”
Click on the tiny Comment form link on this page: http://www.idsociety.org/templates/content.aspx?id=32212267305
Contrary to other reports, the survey is quite simple. On the first page, enter your information. Note that all fields must have an entry. For organization, you can use SASH, or make something up.
The second page is free-form entry. Feel free to copy and paste this:
Wow, we are perplexed by your invitation for public comments on the review of Lyme disease guidelines. There are 81 questions that you ask yourselves regarding Lyme disease, and yet, never do you ask, “What is OspA?” Of course, the answer to that question reveals that your process is inherently flawed, and simultaneously reveals that the criminal element amongst your panel are driving the process forward without any intent of changing the status quo.
Understanding that criminals do not self-correct, we have no faith in a guidelines review process that adopted fraudulent guidelines in the first place. (Need we remind you of Senator Blumenthal’s antitrust lawsuit in 2006, when he was Connecticut’s Attorney General?) Therefore, we have already presented suggested criminal charge sheets to the FBI and DOJ. We provide input here, as invited and on time, to prevent this process from having only one factually informed comment–that of Dr. Sin Hang Lee.
He wrote, in part,
“It is questionable why the experts in this project plan insist on using antibody tests to diagnose a bacterial infectious disease, an obvious deviation from the standard practice of clinical microbiology in dealing with Lyme disease which is really a systemic infection with periodic bacteremia. Do the IDSA members advocate using Widal test, instead of blood culture, to diagnose typhoid and paratyphoid fevers now? I don’t think so. Therefore, to put it bluntly this Lyme Disease Guideline Project Plan is nothing but a sham designed to maintain the status quo of a dysfunctional system.”
And dysfunctional, it is. Perhaps your medical consensus-dictating crew need a few more reminders.
We’ve seen Dr. Wormser’s recently self-published work on diagnosing Lyme disease with mass spec (http://www.ncbi.nlm.nih.gov/pubmed/25761869 –presumably one of the conflicts he listed), and feel we must remind you that through the years, there has been a pattern of primers manipulation to falsely qualify Lyme tests. (We suggest that perhaps an independent panel should review such research and retract wherever necessary, as this may restore some scientific credibility to your organization.)
Speaking of mass spec, it appears IDSA and CDC have a position:
“Unmet diagnostic needs in infectious disease”
“…A number of new diagnostic technologies for ID are rapidly emerging: e.g., broad-range PCR, next-generation sequencing, and matrix-assisted laser desorption/ionization time of flight mass spectrometry.***
That’s great; just be sure to use the correct primers for both the testing and the validation, okay?
We don’t need a repeat of Dearborn 1994, where you guys got tricked into accepting a test method (which we’re stuck with, to this day) that had no consensus behind it and was fraught with the infamous primers manipulation so as to only identify the HLA-linked arthritic knee cases. That, by the way, is why Senator Blumenthal has the FDA all up in your business. It’s not really about the specialty testing labs. It’s about the lack of validation behind our existing test method, so you’d better make sure any new test methods you introduce meet the FDA’s criteria for validation of a scientific method. We suggest starting with Yale’s patented method (US 5,618,533), or possibly the aforementioned mass spec PCR endorsed by IDSA and CDC, assuming you use CSF ***not blood*** and flagellin DNA. Remember, CDC officer Alan Barbour reported in 1996 that borrelia are not even in the blood; they go right to the brain and other organs.
“Biology of Borrelia Species”
When relapsing fever borreliae are no longer detectable in the blood, they may still be found in organs (120). Although borreliae can usually be recovered from such organs as the spleen, liver, kidneys, and eyes of infected animals (37, 120), the organ usually with the most persistent infections is the brain. Humans with relapsing fever have had borreliae recovered from the cerebrospinal fluid (72). Borreliae can be recovered from the brains of animals that are immune to challenge with that strain (119, 127, 148, 178). Detection or isolation of borreliae from brains of animals that had been infected several months and up to 3 years previously has been reported (12, 181, 197, 223). Before the advent of modem ultracold freezers, strains were kept in the brains of rodents and passed once or twice a year (92).
We feel we also must remind you of Mark Klempner losing his job as head of the bioweapons lab in Boston. It had something to do with his “retreatment” study that cost $5 mil, but failed to actually retreat 2/3 of the patients, AND used the fraudulent Dearborn method to identify participants in the first place. Unfortunately, that study was the basis for your reapproval of existing Lyme guidelines in 2001; it was mentioned about 20 times in your report. That must be embarrassing for you all, first being hoodwinked at Dearborn, then losing the LYMErix vaccine, then getting sued over Dearborn, then reaffirming all the utter nonsense ANYWAY, using a fake study based on Dearborn! Funny how things come full-circle, isn’t it?
Speaking of that LYMErix vaccine, maybe that is another good reminder of why we are in this situation at all. You have to admit, it has gotten pretty bad. With 20,000,000 missed diagnoses since 2004 surely you guys are weeding through quite a few very heartfelt comments. (See CDC’s data on reported cases and calculate the actual projected incidence based on a 15% report rate and actual incidence being 12 times higher. http://www.cdc.gov/lyme/stats/chartstables/reportedcases_statelocality.html)
Should we remind you that the FDA demanded that LYMErix be pulled voluntarily, or else they would pull it themselves? Should we remind you that the reason it was pulled is that it caused the same systemic disease as Lyme acquired from a tick bite? Or that its antigen was OspA, which would make OspA seem pretty important, yet OspA was left out of the testing that was rubber-stamped at Dearborn?
Consider yourselves reminded. And now, we come to a crossroads. As we see it, you have one choice:
Either you treat the Dearborn “Steere’s Knee” Lyme disease, or you treat the true relapsing fever borreliosis, post-sepsis syndrome disease that features chronically reactivated herpesviruses which are well known to lead to the “New Great Imitator” outcomes and cancer.
In conclusion, we see what you did at Dearborn, so don’t even think about another shell game with mass spec.