Archive for the ‘Testing’ Category

CDC Slams Long-term antibiotics for Lyme Disease

CDC study slams Lyme disease treatment with long-term antibiotics

Last Friday, the Centers for Disease Control (CDC) released a report which is adding fuel to the fire in the debate about the existence, and treatment, of “chronic Lyme Disease.”

CDC Morbidity and Mortality Weekly report, “Serious Bacterial Infections Acquired During Treatment of Patients Given a Diagnosis of Chronic Lyme Disease,” states that “chronic Lyme disease” is not a scientifically verifiable illness, and that treatments of prolonged antibiotic therapy are ineffective at best, and at worst, potentially fatal.

“Clinicians, health departments, and patients have contacted CDC with reports of serious bacterial infections resulting from treatment of persons who have received a diagnosis of chronic Lyme disease,” the report states.

The study highlights case histories of five patients who were treated for chronic Lyme disease with long-term antibiotics. Complications included septic shock, Clostridium difficile colitis, osteodiscitis, abscess, and in two cases, death.

“These cases highlight the severity and scope of adverse effects that can be caused by the use of unproven treatments for chronic Lyme disease,” the report states. “In addition to the dangers associated with inappropriate antibiotic use, such as selection of antibiotic-resistant bacteria, these treatments can lead to injuries related to unnecessary procedures … and missed opportunities to diagnose and treat the actual underlying cause of the patient’s symptoms.”

Patients in the study were treated with intravenous antibiotics with a PICC (peripherally inserted central catheter). The surgically inserted line injects the antibiotic directly into the bloodstream on the theory that oral antibiotics don’t work as well because they don’t break the blood-brain barrier. The new study took a dim view of PICCs, stating that they were consistently a source of infection.

Regarding the scope of the three-year study, a CDC spokesperson told The Times in an email, “CDC has periodically heard from state health departments and clinicians about patients who have acquired serious bacterial infections during treatments for what is sometimes referred to as ‘chronic Lyme disease.’ We have heard of many cases, but limited the report to five examples.”

Test questioned

The blood tests currently used to detect the presence of Borrelia burgdorferi bacteria, which cause Lyme disease, are the enzyme-linked immunosorbent assay (ELISA), and the Western blot test, which can confirm the results of an ELISA test.

Chronic Lyme disease advocates believe that current testing methods are inaccurate, and a major source of their concern. Last week’s CDC report also addresses this: “There is a belief among persons who support the diagnosis and treatment of chronic Lyme disease that Borrelia burgdorferi can cause disabling symptoms even when standard testing is negative, despite evidence that the recommended two-tiered serologic testing is actually more sensitive the longer Borrelia burgdorferi infection has been present. Some practitioners use tests or testing criteria that have not been validated for the diagnosis of Lyme disease. A significant concern is that after the diagnosis of chronic Lyme disease is made, the actual cause of a patient’s symptoms might remain undiagnosed and untreated.”

According to a CDC spokesperson, “You may have heard that the blood test for Lyme disease is correctly positive only 65 percent of the time or less — this is misleading information. As with serologic tests for other infectious diseases, the accuracy of the test depends upon the stage of disease. During the first few weeks of infection, the test is expected to be negative. Several weeks after infection, currently available two-tier testing has very good sensitivity … Antibodies against Lyme disease bacteria usually take a few weeks to develop, so tests performed before this time may be negative even if the person is infected. It is not until 4 to 6 weeks have passed that the test is likely to be positive. This does not mean that the test is bad, only that it needs to be used correctly.”  (Please see comment at end of article)

Sam Telford, an expert on tick-borne diseases and professor of infectious disease and global health at Tufts University, former MV Times columnist, and chronic Lyme disease skeptic, told The Times that the new CDC report is “yet more evidence” that people should question a chronic Lyme disease diagnosis if the traditional tests show no trace of Borrelia burgdorferi. “When the evidence for a diagnosis rests on testing by a handful of specialty laboratories, in the face of evidence from well-validated tests that have been in use for 30 years, it seems to me that they are limiting their chances for a different diagnosis and treatment to improve life … I think that to the detriment of their health, some people with true illness embrace a faith-based diagnosis instead of an evidence-based [scientific] diagnosis. The CDC report shows what can happen … very tragic. There are many possible diagnoses for the signs and symptoms experienced by those who undergo such extreme treatment regimens.”

Theories behind lingering Lyme

Most people infected with Lyme disease are cured with a two- to four-week regimen of strong antibiotics, most often doxycycline. However, roughly 10 percent of those infected experience long-term symptoms that include muscle ache, joint pain, fevers, cognitive impairment, and extreme fatigue.  (See comment at end of article)

The Centers for Disease Control (CDC) calls this condition post-treatment Lyme disease syndrome (PTLDS), and unlike chronic Lyme disease, the industry-standard blood tests confirm the presence of the Borrelia burgdorferi bacterium.

“The good news is that patients with PTLDS almost always get better with time; the bad news is that it can take months to feel completely well,” the CDC website states. The CDC does not recommend use of long-term antibiotics for PTLDS. “Regardless of the cause of PTLDS, studies have not shown that patients who received prolonged courses of antibiotics do better in the long run than patients treated with placebo.”

There is a growing faction that believes chronic Lyme disease exists irrespective of CDC studies, and that people presenting with persistent Lyme disease symptoms should be treated with long-term antibiotics.

On a visit to Martha’s Vineyard Hospital last summer, Dr. Nevena Zubcevik, attending physician at Harvard Medical School and co-director of Dean Center for Tick Borne Illness at Spaulding Rehabilitation Hospital in Charlestown, said she believes the current testing methods are inadequate.

She cited information from a researcher at the CDC: “Barbara Johnson, an expert with the CDC Lyme program, reveals that the current two-tier method is positive in only 31 percent of those with erythema migrans (the bull’s-eye rash associated with Lyme disease) and in only 63 percent of those with acute neuroborreliosis or carditis due to Lyme disease. This means that out of 100 patients who have Lyme disease, we might misdiagnose 69 of them, leaving their infections untreated … Given the current urgent state of affairs, we should be racing to find better testing strategies that will identify all of the Borrelia species and associated co-infections, and to find better antibiotic regimens that will cure our patients.”

Dr. Zubcevik suggested that the correct antibiotics aren’t being used to treat the long-term symptoms of Lyme disease. She diagnoses this condition as “persistent symptoms related to Lyme disease,” not chronic Lyme disease. “The drugs we are using might be contributing to persistent bacteria, and may not be fully clearing infections,” she wrote in an email to The Times last year.

Dr. Zubcevik did not respond to The Times’ request for comment on the new study.

Though her stance is controversial, it resonated on Beacon Hill. Last July, the House of Representatives, overriding Governor Baker’s veto, passed a bill requiring health insurance providers to cover the cost of long-term antibiotics. Massachusetts was also one of the first states to enact a bill protecting doctors who prescribed long-term antibiotics, when Governor Deval Patrick signed it into law in June 2011.

Enid Haller works as a patient advocate at the Dean Lyme Center, where a number of Vineyarders, and people from all over the country, go for treatment. Ms. Haller also runs the Lyme Center of Martha’s Vineyard, described on her website as a walk-in information service for Lyme and tick-borne diseases, on Panhandle Road in West Tisbury.

Ms. Haller told The Times she believes the CDC, and Mr. Telford, are wrong about the accuracy of the ELISA and Western blot tests. She said she suffered the long-term effects of Lyme disease for more than 10 years, and never tested positive for Lyme disease with the traditional tests given at Martha’s Vineyard Hospital. “The Igenex test is essentially a better implemented Western blot test,” she said. “I came back very positive for Lyme [disease] with the Igenex test.” Ms Haller said the Igenex test should be the standard test for the Cape and Islands, including Martha’s Vineyard Hospital. She said the Dean Lyme Center at Spaulding Hospital in Charlestown uses the Igenex test, and her treatment there has been the breakthrough she’d sought for more than a decade. She said getting the antibiotics intravenously, through a PICC line, was the key.

“It worked incredibly well,” she said. “I had my PICC line removed last November because you have to take it out after a year, because the tubing starts to deteriorate. After the holidays, the symptoms slowly started to come back, the joint pain, the brain fog; I had trouble walking. But a month ago I had a PICC line put back in, and I started feeling better in 48 hours. The pressure in my head just went away.”

Ms. Haller said she feels well enough to join four other Spaulding patients who are traveling to Germany in three weeks for “hyperthermia treatment,” a process where the body temperature is raised enough to kill Borrelia burgdorferi. “I’ve spoken to a lot of people who’ve gotten better from it. I know I can’t be on antibiotics forever,” she said.

Conspiracy theorized

Ms. Haller said she thinks last week’s release of the CDC report was in response to an “uprising,” spearheaded by four people from Lyme Cryme, a chronic Lyme Disease advocacy group, who traveled to Washington, D.C., two weeks ago to lobby congressmen. Lyme Cryme members allege that there has been a coverup orchestrated by the CDC, and that the agency has long advocated ELISA and Western blot tests, knowing that they don’t work. “They’re starting a class-action lawsuit against the CDC, so it doesn’t surprise me the CDC came out with the article last week,” Ms. Haller said.

A 249-page treatise by the $ociety for the Advancement of $cientific Hermeneutics ($A$H), titled “Descrambling the Centers for Disease Control and Prevention’s (CDC’s) For-Profit scientific nonsense,” also alleges CDC perfidy, with an underlying profit motive. “We don’t test positive on the stupid test because it was designed to fail. It was designed to market a vaccine, not diagnose Lyme disease. A core group of doctors with financial interests in the Lymerix vaccine have intentionally misled the medical community about them … At some point, it was decided by CDC officers that they should commercialize Lyme and other emerging tick-borne diseases by patenting vaccines and test kits … Their plan: Make Lyme only 15 percent detectable so that the Cabal would be guaranteed to have an at least 85 percent ‘effective’ vaccine. If they maliciously discredited the people who became ill as a result of the ‘vaccine’ itself (septic shock) or vaccine failure (Lyme), then the vaccine would be ‘safe,’ too. We call both the crime of falsifying the testing and the resultant — and current — bogus testing criteria, ‘Dearborn.’”

Ms. Haller alleged Mr. Telford is also involved in the deception. “Sam owns part of the vaccine,” she said. “Whenever he speaks on the Vineyard, he’s always pushing the vaccine. I always wondered why. I would be interested to know the other doctors who own the vaccine, because they stand to make a lot of money. This is getting exposed now, and I think that’s why Sam gets so mad when we discuss this.”

Ms. Haller said she knows people who have gotten sick from Lymerix, which was introduced in 1998 and withdrawn three years later amid a class-action lawsuit alleging it caused arthritis-like symptoms. “I know people who have dementia because of the Lymerix vaccine, and Sam refuses to acknowledge that. The veterinarians use it, but I know many people on the Vineyard who have given it to their dogs or cats or horses, and they have terrible reactions to the vaccine. They’re probably still making millions and millions of dollars from that.”

In an email to The Times, Mr. Telford dismissed the CDC conspiracy as “ravings,” and stated he has no financial interest or motives with Lymerix. “In 1991, I co-discovered the mode of action of the vaccine … that is all. I did not make the vaccine. I own no patents, never did, received no funding other than to help run the Phase II clinical trial back in the mid-1990s, receive no funding now, and am not pushing it for any financial gain. I hope to revive Lymerix under a nonprofit structure … vaccines for the people by the people. I am pushing for this because I am outraged that Lyme incidence keeps going up and up, and something I helped develop as a younger scientist might have prevented hundreds of thousands of cases over the past decade … and could do so in the decade to come.”

Prevention remains the key

Prevention is paramount when it comes to fighting the spread of Lyme disease and other virulent tick-borne diseases — babesiosis, spotted fever, Rocky Mountain spotted fever, tularemia, Powassan virus, and ehrlichiosis — by wearing permethrin-treated clothes when working or playing outdoors, and making daily tick checks.

This is especially crucial in the months May through early July, when the vast majority of infections will take place.

More information on tick-borne disease prevention can be found on the Martha’s Vineyard Boards of Health Tick-Borne Disease webpage.


**Comment:  The probability of a false-negative test for LD with a single test for early-stage disease was high at 66.8%, increasing to 74.9% for two-tier testing.  For late-stage LD, the two-tier test generated 16.7% false negatives.  Using clinically representative LD test sensitivities, the two-tier test generated over 500 times more false-negative results than two-stage HIV testing.  There is no test for active Lyme disease infection, and test interpretation, especially the use of specific bands in the WB (IgM 2/3; IgG 5/10), developed at the 1994 CDC/Association of State and Territorial Public Health Laboratory Directors Dearborn meeting,6 is problematic. Some doctors and researchers believe those bands were selected only to protect the then-in-development Lyme disease vaccine (subsequently licensed and withdrawn over 4 years). Furthermore, the Lyme ELISA used for screening may not react with serum antibodies if at least a month has not elapsed between the tick bite and the test. If antibodies do develop, research in the Journal of the American Medical Association7 has shown that the antigen and the antibody produced by the patient can form a complex. Current commercial tests can only test for a free antibody, not an antibody in a complex, so patients can remain undiagnosed despite having produced antibodies.

Perhaps most noteworthy is that FDA-cleared commercial serological tests are based on one strain of Borrelia burgdorferi bacteria in contrast, for example, to a 2-strain Lyme test developed by one independent Clinical Laboratory Improvement Amendments-approved lab. The recent discovery by Mayo Clinic/CDC of the Borrelia mayonii species in the Midwest, which can also cause Lyme, and the acknowledgement that Borrelia miyamotoi, a spirochete closely related to the relapsing fever bacteria and more distantly related to the Lyme bacteria, causes a Lyme-like disease in the United States, means Ixodes scapularis ticks transmit all three of those bacteria, further clouding the diagnostic picture.  (And, isn’t picked up at all with current CDC testing)  Please read this fantastic article about the abysmal testing by Lonnie Marcum of


Also, what the Lyme denialists fail to comprehend is that borrelia can move quickly into the Central Nervous System.  While they advocate a “wait and see” approach, the spirochetes are having a hey-day infiltrating every organ.  They advocate a catch-22 telling everyone Lyme is cured by being treated quickly but then they sit on their laurels waiting for a optimal test result that may take up to a month.  Makes absolutely no sense.


ADH: PCR Not FDA Approved

The Arkansas Department of Health is repeating the mantra of the CDC – do NOT use tick borne testing that isn’t FDA approved.  The bad-boy tests include: Lyme Polymerase Chain Reaction (PCR) tests, capture assays for antigens in urine, reverse Western Blots, and antibody measurement in joint fluid.  

Owner of Any Lab Test, Sean Donnegan, is offering the PCR anyway due to it’s lower closet (about $200 – half the price of CDC approved tests), simplicity (1 blood draw that takes 15 minutes) and good results in a mere 5 days.

The ADH and CDC believe there’s too many false positives and negatives in the bad boy testing and would rather own the monopoly on testing which misses over half of all cases.  

Video here (the video uncorrected states this PCR test is FDA approved):§ion=home“>§ion=home

For more on testing, please see: Fantastic article here.

IGeneX is another lab that uses TBI (Tick borne illness) testing that is NOT FDA approved yet is CLIA lab approved and used by most LLMD’s (Lyme literate doctors trained by ILADS). It is a far more sensitive and accurate test in a laboratory that specializes in virology and bacteriology; however, please realize some of the sickest patients never test positively as the tests measure antibodies NOT organisms.  This is why it’s important to see a LLMD as they are experienced and educated in symptomology and other parameters that help them make a clinical diagnosis.  



Who Controls the Fake Lyme Disease News?

Due to a recent report in Morbidity and Mortality Weekly Report (MMWR) Lyme patients will have a more difficult time getting IV therapy, which the CDC has dubbed “unproven.”  The report cites 5 examples….. ,

The Washington Post also just printed this:

Let’s just say, it ain’t pretty.

The CDC came out with this video of a guy who started going blind and had a tumor.  We were never told if he went on the IV antibiotics after a Lyme diagnosis, but he mentioned being told he needed it.  The verbiage under the Youtube video claims he did long-term antibiotics. It also pushes the “FDA-cleared, fully validated tests,” that we all know are abysmal and miss over half of all cases.  Same crap different day.


IGeneX and other small labs that specialize in virology and bacteriology are vilified by the CDC/IDSA and most main stream doctors.  It is a CLIA certified lab, unlike the main labs that give the standard two-tier Lyme Test that is abysmal.  Don’t fool yourself.  This is about money and power.


Pat Smith, President of Lyme Disease Association, has written this rebuttal:

Who Controls Fake Lyme Disease News?

14 June 2017

From the Desk of Pat Smith, LDA
The time has come when the public is entitled to know who in government or elsewhere is controlling the treatment of Lyme disease. 43 years into the disease, patients who can range from just infected to seriously debilitated with long-standing disease, are all thrown the same tired old bone, 3 weeks of doxycycline.

Scientists who are able to publish the science behind longer-term treatment have their science ignored.  The public is not told about persister cells being discovered which appear to be able to survive initial antibiotic treatment; they are not told about biofilm formation; they do not know about the Lyme bacteria hiding in different types of tissues. They are not told about the animal studies which show survival of the spirochete after treatment.

Government-funded NIH research has featured the same old studies with nothing new to offer sick patients, apparently due to the “experts” refusing to sit on peer review on studies with patients with long-tern symptoms–they do not believe in chronic Lyme.  New technology is ignored.

Advocates are blamed for incorrect information being posted on the net, for spreading junk science, for misunderstanding the science, for vaccine failure, for misleading patients, for promoting chronic Lyme, etc. etc.

Patients are categorized as hysterical, needing psychiatric care, having symptoms after treatment no different than those of the normal population– bottom line, not physically sick. These Lyme denialists offer them a pat on the head and show them the door, all the while chanting the “no chronic Lyme” mantra, clueless as ever as to what might be wrong with these patients or how to cure them.

Treating physicians are excoriated for caring about patients, spending hours of time with them to make a clinical diagnosis of Lyme disease and oftentimes, co-infections. They are forced to test with antiquated technology using restrictive band definitions, tests which should have been scrapped years ago, band restrictions that never should have been imposed. Meanwhile, they look over their shoulder to check out whether the “Lyme police” are coming after them and their medical licenses, in part due to the Draconian Infectious Diseases Society (IDSA) guidelines imposed upon them and their suffering patients: 3 weeks of doxy, nothing else, perhaps a psychiatrist, or what often happens to these patients, a “goodbye, live with it.”

CDC has only endorsed and posted the IDSA guidelines on their website, despite the fact those guidelines are stale and have long ago been removed from the National Guidelines Clearing House, set up under the auspices of the US Department of Health & Human Services.  The Lyme Guidelines from the International Lyme & Associate Diseases Society, ILADS, doctors who truly have an understanding of the disease and work in the trenches to provide real medical help versus false erudition, are posted on the National Guidelines Clearing House, which indicates they meet the Institute of Medicine Standards for Guidelines.

Why does CDC refuse to put up ILADS Guidelines? They feel IDSA guidelines are the best guidelines, nothing concrete to support that assertion, since the ILADS guidelines are supported by IOM standards.  Shouldn’t physicians be able to evaluate guidelines supported by IOM standards and accepted by the Guidelines Clearinghouse in relationship to stale guidelines not posted by HHS on its own National Guidelines Clearinghouse?

Too many people are getting sick, too many people are developing chronic disease, so now CDC has published in MMWR, an article titled “Serious Bacterial Infections Acquired During Treatment of Patients Given a Diagnosis of Chronic Lyme Disease — United States”Natalie S. Marzec, MD; Christina Nelson, MD; Paul Ravi Waldron, MD; et al.
Sharing horror stories a few patients experienced with IV treatments for Lyme, the CDC has shut down all long term treatments with antibiotics and with immunoglobulin. The CDC informed the Lyme Disease Association this morning that CDC felt this article was for the good of the patients, who don’t understand the dangers of IV treatments.

For the good of the patients, we need to know who ultimately controls Lyme. Why are “they” refusing to allow cutting edge testing, refusing to provide resources to improve poorly performing tests equivalent to underperforming tests with a Federal imprimatur, or refusing to allow broader band inclusion in existent testing?

Why won’t they permit long-term antibiotic treatment for humans when 70+ % of antibiotics in the US are used to fatten animals and are known to be causing antibiotic resistance; why stress the dangers of IV treatment for Lyme when other diseases such as cancer and HIV use IV and have not been singled out to warn patients of dangers; why do they refuse sick patients treatment that is based on physician judgement grounded in their assessment of the best science?

Why don’t they encourage further clinical trials to supplement flawed, underpowered trials; why do they acquiesce to dangerous policy pronouncements to assume–totally indifferent to patient health costs/benefits–that tests are false positive? Why don’t they fund research looking at chronic symptoms yet they do ignore the good science supporting post-treatment persistent infection.

43 years into the disease, with almost 400,000 cases in 2015 using CDC’s own 90% not reported calculations, we have no accurate test, no cure, and more questions than answers. To shape good public health policy for the good of patients, in place of fake news, let’s have real answers really soon.

Click here: Pat Smith in article on CDC limiting Lyme treatment






LDA President Pat Smith on Contagion Live

Patricia Smith, President of the Lyme disease Association, discusses Lyme disease has spread throughout the United States in the past decade. Part 1

Lyme Disease: What Makes Diagnosis & Treatment Difficult? Part 2

How Have Tick-Borne Diseases Grown in the United States? Part 3

What Do I Need to Know About Lyme Transmission Time? Part 4

Are Patients Facing Difficulties in Accessing Treatment for Lyme? Part 5

Why is May Lyme Disease Awareness Month? Part 6

How Does Government Acknowledgement of Lyme Affect Patient Care? Part 7

The Current State of Lyme Disease Prevention. Part 8

Lyme Disease Legislation May Advance Patient-Centered Research. Part 9

Medicine is Behind the Times When it Comes to Treating Lyme

MAY 24, 2017 | PAT SMITH

Is the Medical Community Behind the Times When It Comes to Treating Lyme?

 Lyme disease has been recognized in the United States for more than 40 years, with about 400,000 new cases occurring in 2015, according to the Centers for Disease Control and Prevention (CDC). Nineteen tick-borne diseases now affect Americans, and one tick bite can cause more than one disease. A recent CDC study uncovered that ticks that cause Lyme disease are found in 50% of continental US counties.1 In addition, according to the results of a large Johns Hopkins University study, as many as 36% to 63% of patients with Lyme disease go on to develop chronic symptoms (posttreatment Lyme disease).2
Major problems surrounding Lyme disease today include reliance upon dogma, promoting beliefs people are expected to accept without questioning or doubting, and the use of selective science by many in the medical community, the Lyme “experts,” who often blame the patient, the internet, and treating doctors with divergent opinions for their own lack of successful patient outcomes. They continue to approach Lyme with a “cookbook” approach. Patients are told the symptoms are “in their head,” that they need to stop reading the internet, or parents of patients are accused of Munchhausen by proxy syndrome (ie, making their children sick). These experts neither want to understand why their approach does not work, nor do they want to take the necessary time to understand the disease by researching and reading all the science, not just that which supports their unsuccessful treatment approach. Steeped in dogma, they ignore the fact that Lyme is meant to be a clinical diagnosis using testing as an adjunct.

Lyme clinical practice guidelines (CPGs) (eg, Infectious Diseases Society of America [IDSA] guidelines) often used by these physicians to treat Lyme are outdated and not posted on the National Guidelines Clearinghouse (NGC) These guidelines are most often used to deny treatment to patients with chronic disease, and so their current absence from the NGC is beneficial to patients who may need long-term antibiotic therapy and have been denied this through use of these guidelines. The only Lyme CPGs available on the NGC are those adhering to newly revised National Academy of Medicine, formerly Institute of Medicine, standards for guidelines− the International Lyme and Associated Diseases Society (ILADS) Lyme Guidelines,3 which address the usefulness of antibiotic prophylaxis for tick bites, the effectiveness of erythema migrans (EM) treatment, and antibiotics’ role in retreatment of persistent Lyme disease symptoms.

Many physicians solely rely on the two-tiered indirect Lyme tests recommended by the CDC and the outdated guidelines. These recommendations include a positive/equivocal enzyme-linked immunosorbent assay (ELISA) followed by western blot (WB), and the tests that are US Food and Drug Administration (FDA)-cleared (substantially equivalent to a predicate test),4 yet not necessarily approved. To date, the FDA has not been able to provide Lyme Disease Association, Inc., with any information on any FDA-approved test for Lyme, including the original predicate test.  According to research in BMJ,5 the two-tiered system, although very specific for Lyme disease (99%)—yielding few false-positives—has a uniformly low sensitivity (56%), missing 88 of 200 patients with Lyme. The current archaic Lyme tests remain unreliable decades later. By comparison, AIDS tests have a sensitivity of 99.5%, missing only one of 200 infected patients.

Additionally, there is no test for active Lyme disease infection, and test interpretation, especially the use of specific bands in the WB (IgM 2/3; IgG 5/10), developed at the 1994 CDC/Association of State and Territorial Public Health Laboratory Directors Dearborn meeting,6 is problematic. Some doctors and researchers believe those bands were selected only to protect the then-in-development Lyme disease vaccine (subsequently licensed and withdrawn over 4 years). Furthermore, the Lyme ELISA used for screening may not react with serum antibodies if at least a month has not elapsed between the tick bite and the test. If antibodies do develop, research in the Journal of the American Medical Association7 has shown that the antigen and the antibody produced by the patient can form a complex. Current commercial tests can only test for a free antibody, not an antibody in a complex, so patients can remain undiagnosed despite having produced antibodies.

Perhaps most noteworthy is that FDA-cleared commercial serological tests are based on one strain of Borrelia burgdorferi bacteria in contrast, for example, to a 2-strain Lyme test developed by one independent Clinical Laboratory Improvement Amendments-approved lab.  The recent discovery by Mayo Clinic/CDC of the Borrelia mayonii species in the Midwest, which can also cause Lyme, and the acknowledgement that Borrelia miyamotoi, a spirochete closely related to the relapsing fever bacteria and more distantly related to the Lyme bacteria, causes a Lyme-like disease in the United States, means Ixodes scapularis ticks transmit all three of those bacteria, further clouding the diagnostic picture.

There has been considerable research over the past several years supporting the existence of chronic Lyme, including the discovery at Northeastern University that persister cells are formed by B. burgdorferi.8 These cells go dormant when treated with antibiotics, but can grow again after treatment stops. Persisters are found in other diseases as well. Work at Johns Hopkins has also been done on persisters: research in Emerging Microbes & Infections,9 “…identified 165 agents approved for use in other disease conditions that had more activity than doxycycline and amoxicillin against B. burgdorferi persisters. The top 27 drug candidates from the 165 hits were confirmed to have higher persister activity than the current frontline antibiotics.” Additionally, work on biofilms in Lyme, by researchers from the University of New Haven, and published in European Journal of Microbiology & Immunology,10 demonstrated for the first time “…the presence of Borrelia biofilm in human infected skin tissue.”

The results of several animal studies have shown that the Lyme spirochete survives antibiotic treatment for Lyme disease, including a University of California mouse study,11 a Tulane monkey study,12 a Cornell dog study,13 and a National Institutes of Health human xenodiagnosis study.14

As new research continues to unlock persistence mechanisms used by B. burgdorferi, the medical community needs to avail itself of those scientific findings by attending continuing medical education conferences and grand rounds and partaking in preceptorships that foster divergent views. The medical community needs to support further research on why some individuals remain sick. It is imperative that healthcare professionals learn how to change that outcome rather than relying on outdated methodologies that have not benefited patient health.

**Patricia Smith (Pat), President of the Lyme Disease Association, Inc., graduated from Monmouth University. She has been involved with Lyme disease issues for 33 years and is a Member of the Columbia Lyme & Tick-Borne Diseases Research Center Advisory Committee, the Congressionally Directed Medical Research Programmatic Panel on Tick-Borne Diseases, and the Environmental Protection Agency Pesticide Environmental Stewardship Program. She has twice testified before US House Subcommittees on Lyme and is former Chair of the NJ Governor’s Lyme Disease Advisory Council. She has published on and been interviewed for broadcast, electronic, and print media on Lyme and tick-borne diseases.  

GLD Announces New Test For Lyme Disease Now Available

Press Release:  June 5, 2017

“We are pleased to provide a much-needed Lyme-specific diagnostic solution,” said Mickey Ramchandani, CEO of Global Lyme Diagnostics. “We look forward to working with the community to advance Lyme Disease screening, awareness and education.”

The GLD Test is based on research by Dr. Richard Marconi, a professor of microbiology and immunology in the School of Medicine at Virginia Commonwealth University in Richmond, VA.

“Like so many researchers in the field, I was receiving an astonishing number of phone calls and emails from patients in distress. The stories were at times heartbreaking,” said Dr. Marconi. “When we realized that recent advances made in our lab could lead to the next generation of Lyme disease diagnostics we seized the opportunity.”
“We have been able to identify the appropriate diagnostic antigens that allow for detection of early stage disease. Using novel chimeritope technology, we have constructed diagnostic antigens that are specifically designed to detect Lyme disease strains regardless of their geographic region of origin,” explained Dr. Marconi.

After licensing the technology platform and related intellectual property Global Lyme Diagnostics focused on creating a highly accurate and reproducible solution.

The GLD Test keeps the prescribing by clinicians simple, requiring only a blood draw.

Dr. Neil Spector and Dr. Rawls on People’s Pharmacy Radio Program

Tune in to Dr. Rawls on The People’s Pharmacy

What You Need to Know About Lyme Disease
Dr. Rawls appears with Dr. Neil Spector on the nationally acclaimed radio program, The People’s Pharmacy, in an enlightening discussion on Lyme disease. Listen to the on-air radio broadcast at 7 a.m. (EDT) June 3, or the replay airing on June 4 at 3 p.m. (EDT). Listen to it live on your local radio station or access the recorded podcast available Monday.


Lyme diseaseThere’s been a big increase in mouse populations in many places over the past year. As a result, the number of ticks is booming, and you have a greater chance of being bitten when you go outside. Could a bite put you in danger from Lyme disease?

The Basics of Lyme Disease:

Lyme disease is the name given to a constellation of symptoms in reaction to infection with a tick-borne pathogen called Borrelia burgdorferi. The black-legged tick, Ixodes scapularis, is the usual culprit in transmitting this germ. Black-legged ticks feed on white-tailed deer and white-footed mice as well as humans, hence the name “deer tick.”

The infection can produce a rash (though it doesn’t always), along with fever, chills, joint pain, fatigue, headache and flu-like symptoms. If left untreated, Borrelia infection can cause more serious symptoms, including arthritis, pain in muscles and tendons, heart symptoms due to inflammation of the heart muscle and neurological symptoms from inflammation of nerve tissue. Some people also experience brain fog or problems with memory and concentration.

Lyme Disease Stories:

Both of our guests on today’s show are physicians, and both have suffered with Lyme disease that went undiagnosed and untreated for many years. In Dr. Spector’s case, the primary symptoms were heart rhythm abnormalities as the infection destroyed his heart. He eventually needed a heart transplant. (He wrote Gone in a Heartbeat.)

Dr. Rawls also had cardiac symptoms, in addition to fatigue and many other problems. When he finally figured out what was happening to him, he developed a multi-modal treatment plan incorporating herbs to modulate his immune reaction. He also wrote a book, Unlocking Lyme.

Diagnosing Lyme:

While a bulls-eye rash is usually thought of as the signal of Lyme disease, not all target-shaped rashes are the result of Lyme, and quite a few people with Lyme disease never notice a rash. Indeed, some are unaware of having been bitten by a tick.

Lyme disease diagnosis is not as straightforward as the diagnosis for certain other diseases. The laboratory tests need to be interpreted by a clinician who is experienced in the use of two-tiered testing.

(IGeneX uses a far more sensitive test.  Learn about it here:

Taking Control:

When patients feel they need to take control for themselves, one resource is ILADS: The International Lyme and Associate Diseases Society.

There is also more information on this website about other tick-borne infections. We discussed Lyme disease, Bartonellosis and alpha-gal allergy in Show 1003. Show 907 covered Bartonella infections in detail.

This Week’s Guests:

Neil Spector, MD, is an associate professor of medicine as well as pharmacology and cancer biology at Duke University Medical Center. He holds the Sandra Coates chair in breast cancer research. Dr. Spector co-directs the experimental therapeutics program for the Duke Cancer Institute and is a Komen Scholar. His book is Gone in a Heartbeat: A Physician’s Search for True Healing.

Bill Rawls, MD, is board certified in Obstetrics and Gynecology. He has written about Lyme disease, fibromyalgia and chronic immune system dysfunction. His books include Unlocking Lyme: Myths, Truths and Practical Solutions and Suffered Long Enough. His website is

Listen to the Podcast:

The podcast of this program will be available the Monday after the broadcast date. The show can be streamed online from this site and podcasts can be downloaded for free. (We’d be grateful for a review on iTunes or Google Play.) CDs may be purchased at any time after broadcast for $9.99.

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