Melissa Wright is the Director of Patient Engagement & Outreach for LymeDisease.org and Project Manager of MyLymeData.
She spoke at the recent Tick-borne Disease Diagnostics online event spons
Lyme is not recognized as a possibility in their area
Many patients do not present with a classic erythema migrans rash
The diagnostic testing for Lyme is flawed
View her presentation here:
Here’s the text of her remarks:
Hello everyone, my name is Melissa Wright and I am the Director of Patient Engagement & Outreach for LymeDisease.org and Project Manager of MyLymeData. I am happy to be with you today for the Tick-borne Disease Diagnostics Innovation Incubator, and have the opportunity to talk with you about the impact of diagnostic delays in the Lyme community.
Founded over 30 years ago, LymeDisease.org, is one of the oldest Lyme disease organizations in the nation. It is the largest and most trusted communications network for Lyme patients. Our mission is to harness the power of tens of thousands of patients to improve patient care and accelerate the pace of Lyme disease research. We do this through providing tools like our symptom checker, physician directory, and the MyLymeData patient registry and research platform with over 15,000 patients enrolled.
Today I’ll briefly discuss diagnostic issues with data from MyLymeData, the current testing and what we’re doing to push the needle
Using a diagram first developed by the Institute of Medicine (now the National Academy of Medicine) in its report “Improving Diagnosis in Health Care,” which identified different points along the path to diagnosis where things can go wrong and diagnosis can be delayed or missed. It has been modified to reflect the diagnostic issues we encounter in Lyme disease. For example:
Lyme is not identified as a possibility in (name your state)
Many patients do not present with a classic EM rash
And the diagnostic testing is flawed
Which leads to a large majority of patients being misdiagnosed.
In MyLymeData we found that 70% of those with late or chronic Lyme disease experienced years of diagnostic delays even though 45% had presented with early symptoms. It had taken the majority, 3 or more years to be diagnosed after seeing 5 or more doctors with 72% being misdiagnosed and likely unnecessarily treated for another disease.
So why the delay? In Lyme disease we know early diagnosis can be a ticket to recovery. 70-80% do become well. Unfortunately, a diagnosis of early Lyme disease is not so straight forward. A lot of the symptoms are not specific for Lyme disease and do occur in other illnesses. So, there’s a big emphasis on whether the patient has distinguishing factors.
– Was the patient exposed to an area where there are ticks that carry the disease? (Remember, no Lyme in name your state)
– Did the patient have a distinctive round rash that could have been caused by the bite of a tick. (only 34% of patients report having a rash)
– And were any blood tests positive? (flawed testing, with 37% receiving a false negative)
In regard to testing, we know during the first four to six weeks of Lyme infection, standard Lyme disease tests are unreliable because most people have not yet developed the antibody response that the test measures, and even later in Lyme the two-tiered testing is highly insensitive.
The chart (Stricker, Johnson 2010) illustrates the studies examining the testing. As you can see, the mean sensitivity for Lyme testing is 46%. This means 108 of every 200 cases is missed in Lyme compared to that of the highly sensitive testing for HIV/AIDS, which has a mean sensitivity of 99.5%, where only 1 in every 200 cases is missed.
Simply put, the likelihood of Lyme disease being diagnosed from a positive lab test is the equivalent of getting a heads or tails in a coin toss. This ultimately means many patients go undiagnosed.
Now everyone knows the saying there is power in numbers, but despite Lyme disease having 475,000 cases annually little has been done to advance Lyme testing or research.
According to research by Goswami, the number of clinical studies for Lyme disease trails behind leprosy–which has an incidence of less than 200 cases per year. So, Lyme disease should be thought of as a research disadvantaged disease that faces the same challenges that rare diseases face.
Patients are the most underutilized resource in medical research, and we are striving to bridge that gap.
The research cycle illustrated is derived from Groft’s work with rare diseases. His model suggests forming a patient registry that links with a biorepository—we are collaborating with the Lyme Disease Biobank here.
The registry helps to develop a research hypothesis—here we have published three peer-reviewed publications to better characterize the disease, assess patient reported outcomes, and analyze treatment effects among patient subgroups. The registry can then be used to help recruit patients. We have worked on recruiting for two clinical studies.
A team research approach will allow rapid knowledge generation to accelerate the pace of research–-leading to improved diagnostics, treatment and care.
Thank you for your time, I appreciate the opportunity to speak with you all today and I want to close by encouraging anyone not yet participating in MyLymeData to enroll.
PCR Proven An Unmitigated Disaster: Italy Reduces its COVID-19 Death Number by 97%. We Tried to Warn You.
The US is hellbent toward chronic worklosses of historic proportions.
James Lyons Weiler
Nov. 2, 2021
Since March, 2020, I’ve been sounding the alarm on the misuse of PCR test results as a proxy for a diagnosis of COVID-19, the disease caused by a SARS-CoV-2 infection. Based on first principles, it was clear to me then that the false positive rate of PCR conducted at high cycle threshold values would lead to far more false positive than true positive test results, leading to the lockdown that eventually happened.
OSHA is about to drop a rule that requires employees in companies with more than 100 workers to submit to a vaccination, or to tested and to mask in the workplace – and there will undoubtedly be a fourth wave when people start testing en masse.
Now, due to the realization that the “died with = died from” paradigm is dependent on the accuracy of the “with” part – which depends largely on PCR test kits. Given the use of high threshold values for “diagnosis” of COVID-19, the rates of cases and deaths have been grossly exaggerated. The evidence is so overwhelming – and coming in from all sources (except the US CDC) that Italy has revised its estimated number of deaths from COVID-19 from over 390,000 to less than 4,000 – overnight.
This means the US is poised for mayhem and chaos.
Fact checkers criticized IPAK for publishing information on the utterly flawed paradigm – and they were proven wrong.
Now, unless OSHA backs down from requiring vaccination or testing, which of course presumes:
the safety of the vaccine (very much in question)
that only unvaccinated persons can spread COVID-19 in the workplace (absolutely false)
that routine, repeated, widespread asymptomatic testing won’t lead to a flood of chronic false positives (impossible)
The OSHA rule will lead to workloss at companies that follow their directive – and the worklosses will be of historic proportion.
Dr. Sin Hang Lee, MD points out that this is not the first time reliance on PCR test results as a proxy for medical diagnosis has led to disastrous results.
Mark Schiffman of the NCI on PCR HPV testing, which leads to >95% unnecessary colposcopic biopsies on hundreds of thousands of healthy women each year. Lee pointed out (personal communication) this passage from Schiffman and colleague:
“Most HPV infections are benign, and over-reacting clinically to HPV positivity can cause psychological and possible iatrogenic physical (e.g., obstetrical) harm. We describe the built-in false positives in current tests, and the real harm that can result when the meaning of such false positive HPV tests is misunderstood. We suggest steps that could reduce harm being done by flawed tests and excessive clinical responses to positive HPV testing.”
We’re already poised for hyperinflation due to the harmful effects of the repeated stimulus payments based on printed money. When the economic shit hits the fan due to worklosses across the companies, well, I tried. Again, I’ve been at this since March, 2020, and others quickly followed suit. It is with no pleasure that I report to the skeptics: We tried to warn you.
I cannot convey the urgency with which we all must act to stop the OSHA rule from dropping. CALL YOUR SENATORS NOW.
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**Comment**
I don’t need to tell Lyme/MSIDS patients that testing has worked in the reverse for tick-borne illness. While false-positives are extremely high for COVID and HPV, testing for Lyme and coinfections is nearly alwaysnegative, an injustice that’s been going on for over 40 years and shows no sign of changing. Further, the CDC has actively suppressed more accurate testing, and one researcher is suing it for using its regulatory power to block widespread application of a highly reliable direct DNA test and for channeling public funds to promote its own patented, but immature indirect metabolomics technology for Lyme disease diagnosis, a technology known to be prone to false positives.
BOSTON, MA (October 25, 2021) — Nonprofit grassroots organization TruthCures met with Food & Drug Administration (FDA) officials last week to discuss issues related to notoriously inaccurate Lyme disease diagnostic tests. The group’s executive director, Laura Hovind, and associate Lahra Tillman were joined by Carl Tuttle, an appointee to New Hampshire Governor John Sununu’s Lyme Disease Study Commission, and their legal counsel, a former federal prosecutor. Kenneth Liegner, M.D., a longtime treating physician, published author and renowned Lyme disease expert participated remotely to demonstrate the deficiencies of the Lyme disease diagnostic method and the harm it does to patients.
At issue are 27 years worth of FDA-cleared Lyme disease diagnostic tests. Lyme disease is a bacterial illness caused by the bite of an infected tick. TruthCures claims the diagnostics are wholly inadequate because they are designed to detect only a small minority of cases predisposed to developing “Lyme arthritis,” a less-severe manifestation of the disease. They cited published literature and historical federal meeting documents that indicate the sicker Lyme disease cases are immunosuppressed and rarely test positive by the criteria that have been in place for nearly three decades.
“We are extremely pleased with the FDA’s response so far and are encouraged by how quickly they understood the problem and began thinking of solutions available to them within the regulatory framework,” said Tillman.
In a detailed presentation, the group explained how Lyme disease researchers’ financial interests in patents for the various bacterial components of diagnostic tests and vaccines have been prioritized over public health. They also shared results of an independent analysis by a diagnostics regulatory expert indicating there may have been irregularities with the process by which Lyme disease diagnostic tests were relabeled in the late 1990s. “We are very concerned that patients were left out of the equation when changes were made to the testing protocol,” said Hovind.
The group requested the FDA’s assistance in investigating the manipulated diagnostic protocol and its far-reaching effects, as well as coordinating with other agencies to evaluate related accepted standards they claim are inadequate. “As a public servant myself, I applaud the FDA investigators’ efforts to understand and act on information provided by concerned citizens,” noted Amy Kissinger, a member of TruthCures’ board of directors. “We are confident in their dedication to do the right thing in terms of the regulatory component of our claims.”
Added Hovind, “Our goal has always been to expose the truth and clear the way for accurate tests so the millions suffering this devastating disease can get the diagnosis and treatment they need. This development should give them hope that someone is striking at the root of the problem, and change is on the way.”
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TruthCures is a registered 501(c)3 nonprofit organization dedicated to restoring a valid case definition for Lyme disease so all affected people can be accurately diagnosed and successfully treated. For more information, visit truthcures.org or email truth@truthcures.org.
Madison Area Lyme Support Group 