Faulty FDA approved antibody tests
Jan 2, 2015 — There has been a deliberate effort to stifle the Lyme patient voice and the complaints regarding faulty FDA approved Lyme disease antibody tests leading to misdiagnosis and disability.
Countless numbers of Lyme patients have been denied treatment and insurance reimbursement as a result of the restrictive case definition. It is time to flood our public health official’s in box with stories of misdiagnosis and personal harm due to the five band IgG criteria which has been estimated to eliminate 95% of active infections per the detailed letter below addressed to Joe Bergantino, Executive Director of the New England Center for Investigative Reporting. (please read)
Former Senator Alfonse D’Amato attempted to address this issue in 1996!!!!
Ignoring patient complaints equals MEDICAL NEGLECT.
If you have been harmed by faulty Lyme disease tests please describe your experience in an email and send that message to the following recipients:
Subject: Faulty/misleading FDA approved antibody tests
Secretary Sylvia Mathews Burwell U.S. Department of Health & Human Services
Senators Richard Blumenthal, Kemp Hannon and John Bonacic. Joe Bergantino, Executive Director of the New England Center for Investigative Reporting. Heather Goldstone, WGBH Science Editor. Beth Daley, Investigative Reporter.
Bcc: Carl Tuttle" <email@example.com>
I will be compiling a document of these complaints to present to legal council in order to establish the feasibility of a class action against (but not limited to) the commercial labs administering these tests, the clinicians misdiagnosing Lyme as a result of these tests, the CDC, FDA and Department of Health & Human Services for ignoring patient complaints.
Please send these complaints on Monday January 5th to Wednesday January 7th in order to project a unified effort from the Lyme patient community. Complaints are welcome after those dates and will be included in any possible class action effort.
Please continue to forward this petition to educate others.
Letter to Joe Bergantino, Executive Director:
From: "Carl Tuttle" <firstname.lastname@example.org>
Cc: "heather goldstone" <email@example.com>, firstname.lastname@example.org, email@example.com, Jmckim@bu.edu, firstname.lastname@example.org, email@example.com, "doug struck" <firstname.lastname@example.org>
Sent: Tuesday, December 23, 2014 8:51:18 AM
Subject: Re: Our next story could save thousands of lives
New England Center for Investigative Reporting
640 Commonwealth Ave
Boston, MA 02215
Attn: Joe Bergantino, Executive Director
Thank you for your recent message regarding faulty prenatal tests.
The following statements from your message struck a chord with me:
“Our most recent story revealed that some prenatal tests-- being taken by hundreds of thousands of women across the nation--are wrong as much as half the time. That's despite claims that those tests are 99% accurate.”
We have a similar problem with Lyme disease antibody tests as my recent complaint with the Massachusetts Medical Board pointed out. A sixteen year old boy was admitted to a psychiatric ward because his Western blot did not meet the five out of ten band IgG criteria for positive results.
Complaint filed with the Massachusetts Medical Board:
Our entire family was treated for Lyme disease and not one of us met the five out of ten band IgG criteria for positive results so all tests stated: NEGATIVE.
Here is one example: (Wife’s Western blot results)
Had we not met Dr Sam Donta who understands Lyme disease and how to interpret antibody markers my wife would have had knee replacement surgery by now.
The CDC surveillance/reporting criteria for positive serologic results require five out of ten IgG bands on the Western blot. In contrast, a single band criterion in China is sufficient to diagnose Lyme disease:
A Study of the Technique of Western Blot for Diagnosis of Lyme Disease caused by Borrelia afzelii in China
Please see the attached Dr David J. Volkman letter to Dr. Thomas Frieden, Director of the CDC regarding the five band IgG criteria for Lyme disease. http://home.comcast.net/~runagain/Dr Volkman letter to the CDC.doc
Per the U.S. Food and Drug Administration website there appears to be four pages of patient complaints regarding faulty/misleading Lyme disease antibody testing and subsequent misdiagnosis:
MAUDE - Manufacturer and User Facility Device Experience
Prior to the CDC announcing the revised 300,000 estimate in Aug of 2012 the number of Lyme disease cases in the U.S. was averaging 30,000 per year. (Those who met the strict five out of ten band IgG criteria “CDC case definition”)
It is believed that the five out of ten band IgG Western blot criteria (for positive results) eliminates 95% of active infections so if the 30,000/yr number represents only 5% of actual infections then the correct number of cases would be in the 600,000 range.
Sexual transmission of Lyme disease (As described in the recently updated Middelveen study) could easily double or triple that number.
Was this five band criterion created to purposely conceal an expanding epidemic?
From the FDA.gov files……Jan 31, 2001
DEARBORN The Illusion of a Conference:
There seems to be reluctance on the part of the New England Center for Investigative Reporting to expose this major testing flaw.
From WGBH: http://wgbhnews.org/post/learn-more-about-lyme-war
“Learn More About The Lyme War”
Heather Goldstone: Why don’t we have better tests?
Dr Ben Beard: What we need to move toward is a whole new paradigm shift in Lyme disease testing looking for direct indicators of infection; proteins, the antigens of Borrelia or markers of human infection or DNA or PCR which is used and I was told recently by a colleague at the FDA that there’s no one single PCR assay that’s FDA cleared for any tick borne disease.
Milford Medical Laboratory (http://www.dnalymetest.com/) can produce a DNA/PCR diagnosis within five days of a sample's receipt, ensuring the fastest, most conclusive test for Lyme disease available anywhere. The diagnosis fee is $150.00 per sample. All tested samples are issued an official laboratory report as well as an accompanying DNA sequencing electropherogram and GenBank BLAST alignment analysis if the result is positive.
Why doesn’t the CDC fund PCR/DNA tests to get them FDA approved for the early detection of Lyme disease before antibodies are produced? This DNA test should be made available in all hospitals of Lyme endemic areas.
The CDC provided Heather Goldstone with lip service as there is absolutely no urgency behind supporting tests that will identify the true extent of this epidemic and confirm persistent or chronic infection.
There is talk on the street that the reason WGBH didn’t offer opposing viewpoints during the Lyme discussion is because it might jeopardize government funding to PBS (http://www.foxnews.com/entertainment/2013/10/08/government-gives-445-million-to-corporation-for-public-broadcasting-on-first/) which I understand amounts to $445 million.
Recent German study: (Jan 1, 2015)
Antibodies against Borrelia burgdorferi sensu lato among Adults, Germany, 2008–2011
“Seroprevalence among the oldest age group indicates that at least one fifth
of the German population becomes infected with B. burgdorferi s.l. during their lifetime.”
CDC article: (Jan 1, 2015)
Use of Treponema pallidum PCR in Testing of Ulcers for Diagnosis of Primary Syphilis