LYME ARTICLES SUMMARY
I am editing a tick disease book that gives me exposure to new data and am in a research email network--I am so weary of waiting 2 years for new findings. My own publication in JAMA took over a year to be published.
Below are some terse materials on Lyme. More if an interest, since field is exploding.
Lyme Testing: The Problems Rarely Appreciated
Many good and sincere physicians have been trained to perceive Lyme testing falsely, and some are even infectious disease consultants.
Lyme is a very sophisticated bug. It is partially related to the bug that causes syphilis. There are literally well over a dozen reasons for missing the diagnosis.
First, that bulls eye rash is a good sign you have it. But 11 other "bite" patterns or rash patterns can also be Lyme. In fact only 1/2 get any kind of mark or rash. And only 25-50% have the popular bulls eye rash. Sometimes a bulls eye rash is not on a part of you body you easily see and so is missed.
- Lyme can hide by a number of ways from your immune system.
- It your immune system is not tuned up and working very well you can be found fully negative on multiple lab tests.
- Most tests for Lyme are antibody tests. Antibodies, also known as immunoglobulins, are proteins that recognize something foreign in the body--like infecting bacteria and help remove it. The first and most common test your doctor usually orders is an ELISA antibody test. Again, since Lyme hides well and most immune systems are fair, you will come up normal or "negative."
- Specifically, the ELISA test missed 56% of confirmed Lyme patients (Archives of Internal Medicine 15:761-0763, 1992).
In another study, it was in some ways worse. In this one the ELISA test missed over 70% of people with early Lyme disease, and 46% with late manifestations of Lyme where it was in the brain or causing severe body damage. (Laboratory Medicine 21:299-304, 1990). Meaning, it missed 70 out of 100 people with the early disease. But it was still negative after the bug was in the body for a long time -- still missing 46 of 100 seriously infected people. Doctors have been sold by these labs on the reliability of these labs and they are hurting possibly as many as hundreds of thousands. After flu's, colds and a few other infections Lyme is at the top of the list. It is in 49 states and is not just a New England or New Jersey issue.
- For some, the Lab is a place of perfect science. A place which has purely objective fact. In Lyme this is not valid. In one study, 55% of the labs could not accurately identify blood samples with Lyme, which led to the conclusion in a prestigious infection journal, that: screening tests for Lyme disease are not adequate (Journal of Clinical Microbiology 35:537-543, 1997).
What About the Western Blot? Is That Definitive?
The Western Blot is merely another antibody test. Our experience in measuring immune system markers is that the immune system is weakened in many with Lyme. So depending on immune system anti-Lyme antibodies is wishful. However, the Western Blot is more specific than the ELISA. The test can test for 25 possible "bands" that relate to parts of Lyme or other infections.
But the routine Western Blot typically done has massive errors. In one serious test of the Lyme Western Blot testers, there was a stunning finding. They used nine clearly infected patients and sent their blood to 18 labs. Of the IgG type of antibody, some labs were wrong. They missed 10 of 18 samples. For the IgM type of antibody, the labs were occasionally so bad they falsely reported Lyme as absent in 16 of 18 samples (Arch Intern Med 150:761-763, 1990).
- Most physicians are taught to do the ELISA first. If that is positive then "confirm" with the Western Blot. The big confusion is that this is not a way to diagnose. It is the CDC's way of generally tracking the movement of Lyme in locations and states. It is not a way to determine whether you, your child, your relative or close friend, individually, have Lyme! It is not the best way to test our precious loved ones.
If you use the Elisa first method with the confirmation Western Blot you miss massive numbers of individuals with Lyme (Journal of Clinical Microbiology 34: 10-9, 1996). From this two-stage approach, you may have a sense that Lyme is entering your state at an increased rate, but that does not address your individual concern.
- The CDC guidelines seem to express clearly to me that these two lab tests were never intended to be the final measure of whether you have Lyme. They report the main diagnostic criteria are what you report to your doctor and what they find on a physical, i.e., "clinical findings." (www.cdc.gov/ncidod/dvbid/lyme/diagnosis.htm)
- Another government agency, the conservative FDA, has issued a bulletin explaining that a person may have active Lyme disease and yet may have a negative lab result. Meaning, diagnosis should be based on the history of what happened to you, symptoms, exposure to the tick and physical findings (www.fda.gov/medbull/summer99/lyme.html).
- Congress and the President have felt that negative labs have been used to keep people from needed treatment. United States Congress Public Law 107-116 explains that labs that are negative have no relation to Lyme diagnosis in a person and refers to the CDC that lab monitoring and testing with Elisa and Western Blot was "developed for national reporting of Lyme disease: it is not appropriate for clinical diagnosis."
Some bands may be fairly specific to Lyme: 12, 22, 23/25, 31, 34, 35, 37, 39, 83, 93. Dr. Charles Jones, who is the leading pediatric Lyme expert in the USA, with over 6,000 treated child Lyme patients, explained to me if a Western Blot done by IgeneX -- the best Tick illness lab in the USA -- comes up positive with only one band, it is a specific positive. It means that "bands" or antibodies specific to Lyme are present.
Finally, some feel the PCR test is the best test. It measures parts of the actual Lyme itself, so it is a direct test.
Most PCR tests are performed by labs that almost offer positive findings -- not even in obviously sick positive Lyme people. Therefore, a PCR test should be done only by IgeneX. (Medical Diagnostic Labs is good for testing the co-infections mycoplasma and bartonella, but they miss many positive Lyme patients. Often with Medical Diagnostic Labs you need to do 5 blood tests to get a positive). PCR testing can have a false negative of 30% in those with positive Lyme. It is also good to test the PCR from blood serum, whole blood and urine, so they have more ways to look for the illness. Urine might be the best since Lyme seems to migrate to the bladder.
Finally, we are increasing using a full SPECT Scan of the brain (and some use a PET scan) to look for areas of non-functioning. It shows areas of inflammation and areas where the brain is not working well, called "hypoperfusion," but the person still seems reasonably functional. If reasonably functional people ignore testing, they may one day be very non-functional, and chronic Lyme is much harder to treat and beat fully the longer it is ignored.
Excerpts from a book in manuscript by: Dan Kinderlehrer, MD.
Dr. Kinderlehrer has been a great help to many of my patients, and I deeply appreciate his willingness to share these thoughts. His book is very comprehensive. It will be a major contribution to Lyme care.
The NY Times and Lyme:
Limited Media Knowledge of Lyme Disease
To the NYTimes: Reporting Lyme Disease in the Media
First, I would like to thank you for sponsoring the Time for Lyme fundraiser last fall.
As you must know, your paper is read nationwide and is respected by many. For this very reason I would like to point out how important it is for correct information to be made available to the general public regarding Lyme disease and its many CO-infections.
Lyme disease is a killer! It is time for medical schools and universities to seriously give attention to educating medical professionals regarding Borrelia burgdorferi, Babesiosis, Ehrlichiosis, Bartonelliosis, Brucellia, Mycoplasmas, and the list goes on ...
As a national Patient Advocate for those who suffer the maladies of Lyme disease, I receive calls almost Every Day from someone who has just been diagnosed but their doctor does not know how to treat this disease.
Lyme disease is bewildering. Its symptoms vary drastically from patient to patient because of CO-infections. So many patients become suicidal because of the difficulty in finding a medical doctor who is educated in this field. It is imperative for the medical community to become informed correctly in methods of diagnosing and treating Lyme disease.
How many will have to die before attention is given to this life-threatening disease?
I would ask you to assign an unbiased reporter to research both sides of the political arena regarding Lyme disease. I mean, really delve down deep into the science and proven documentation. Not just discuss the political correctness between opposing parties.
It is appalling to discover so many patients infected with Borrelia burgdorferi (Bb) have been misdiagnosed and improperly treated.
It is time to update the medical books and give serious attention to the devastating affects of this disease.
I live in Central Florida. And yes, ticks are here too! We have the "southern strain" of Bb which comes from the Lone Star tick (Americana Amblyoma). This tick is a very aggressive tick who crawls up trees in search of a blood meal. This tick has now ranged upward along the Eastern Seaboard all the way up to Maine and as far west as Texas!
Would you believe the CDC actually sent letters to veterinarians in Florida warning them to expect Lyme disease to present in small animals and to be on the lookout for it? The reason for this notification was mulch from the northern states had been distributed in Florida and it was found to be infested with ticks!
I would ask you, why didn't the CDC warn medical professionals to be aware of the spreading tick population and possible infection appearing in humans? After all, we play in the mulch too! Why wasn't a public announcement made?
As Lyme disease soars and medical expenses expand to unbelievable heights, it is time for this nation to wake up to the dangers this disease brings to all of us.
It is Time For Lyme!
Marvina Lodge, President
Florida Lyme Disease Network, Inc.
(Printed with written permission)
Dr. James L. Schaller
I have repeatedly seen patients fully normal on dubious routine Lyme titer tests and Western Blot tests, only to explode with symptoms and/or positive tests done at more sophisticated labs a couple weeks later.
Any physician who uses the junk labs commonly used knows little about real Lyme. If they use Specialty Labs or Quest instead of IgeneX, run!
If they only test for Lyme and not the 3 common co-infections that can be carried by ticks, they know nothing about Lyme.
However, I want to talk about how Lyme is occasionally being missed by solid and brilliant Lyme physicians. As I look over this past season, some patients were missed, and I think I know why.
As you may know, Lyme can present with virtually any medical or psychiatric complaint. And since all doctors agree that we cannot do sophisticated expensive testing on everyone, we have to pick and choose.
So who should get tested?
Here is where a person can be burned. Let me show you with a real case.
Laurie is a 45 year-old teacher. The only outdoor experience she has is walking to the mailbox -- even her car is inside the garage. She broke her ankle last year in a fall from a bike. The ankle was supposed to be fully "recovered" according to the orthopedic doctor, but about 3 months after the cast was removed she still had pain in the ankle -- mild pain.
She worried that the doctor did not set the bone correctly or that it had healed wrong.
However, a year later I tested her blood to evaluate her hormones, along with specialized chronic disease prevention labs. I added a few basic Lyme tests that are not reliable for Lyme.
However, two bands showed up that did not qualify her as officially having Lyme. But on sophisticated tests, she was found to clearly have both Lyme and a malaria-like bug called Babesia.
After three months of treatment, including three antibiotics and an anti-malaria medication, she was feeling much better. And her ankle felt great.
When you are infected with Lyme it may first present by making an area of bodily weakness more of a problem. You can tell yourself it is merely the old problem, but it may be the infection and the chemicals the infection and the body creates, causing the resurrection of the old body problem. So if you are prone to migraines, they may get worse. If you are prone to knee aches because of degeneration, they may get worse. But it is actually the Lyme making your weakness more apparent.
It requires a solid expert to help you sift through the old body vulnerabilities and new Lyme making worse.
Dr. James L. Schaller
The C6 Lyme Peptide ELISA
A new Lyme disease test is called the C6 Lyme Peptide ELISA.
While it is also an antibody test, which assumes the antibody system is working well, is has unique aspects.
Lyme has the ability to have many forms and strains. It has ability to hide from the immune system. This test detects antibodies to a newly discovered consistent protein on every known strain of the Lyme disease bacteria.
According to the manufacturer and some researchers, Lyme is able to evade immune system response by many means, including varying its coat seen by our immune system. Much like wearing a different coat in the winter to escape detection after robbing a bank, this allows it "variation."
How often does this disguise change in the Lyme outer coat happen?
One study notes Lyme varies its coat or other outer key proteins on certain days. The clock for coat changes starts after infection in mammals after initial infection on days 4,7,14,21,28, and 7 and 12 months post infection of mammalian hosts. This is utterly amazing, since the infection you get now, is different in weeks and months later (Zhang, Norris - abstract below)
According to the maker, scientists have found a part of the Lyme "coat" that does not appear to change. Specifically, "6 surface proteins" on Lyme remain constant. Scientists call these "invariable regions" (IR), which are termed IR1-6. One IR, IR6 is found in all Lyme strains. The new test is abbreviated, C6 LPE, and detects antibodies to the IR6 in infected patients. (Elisa C6 Peptide Test).
The maker of the test reports: "diagnosis of Lyme disease has been hampered by tests that have not been standardized, are not reproducible, and are neither sensitive nor specific for this often difficult to diagnose tick-borne disease. The recent Lyme disease vaccine, which has been given to thousands of people over the past year, makes current tests for Lyme disease virtually useless. The C6 LPE has several features that ensure its accuracy and reproducibility in a wide range of patients."
BBI Clinical Laboratories, the maker of this lab test, says this new test is useful for:
- Patients that have received the Lyme disease vaccine.
- The ability to detect antibodies to all US and European strains.
- Patients with autoimmune diseases (e.g. non-Lyme arthritis, lupus erythematosis), other spirochete diseases (syphilis, relapsing fever), neurologic conditions, and infectious diseases. Because the C6 LPE is highly specific, people with autoimmune diseases do not yield false positive results as they often do with current Lyme tests.
- Since IR6 antibodies begin to be produced in early infection and are produced throughout the course of infection, the C6LPE is more sensitive for diagnosing all stages of Lyme disease, including those patients with late stage Lyme disease.
Critique and Concerns by Some Clinicians.
Some researchers feel this is a useful contribution to the lab options for testing for Lyme. It is moving through the FDA approval process reasonably as far as I can tell.
Currently, the junk way of testing for Lyme is to check a general titer and the check for the Western Blot "bands." This is called the "two-tiered" approach. While this is a poor system, it is at least occasionally useful, and can allow doctors to think through the values. Meaning, if the clinical picture makes Lyme likely and the tests are marginal, some doctors would feel Lyme is likely positive and treat. If it replaces the other tests, we are back to the simplistic basic approach to Lyme. "Oh, one test will answer all our questions."
One scientist he is not so sure it will pick up late stage patients. I do not know if this is correct.
Other's doubt that the antibody levels will remain constantly high and measurable for months and years.
If it is done, especially as the only test, if it comes back negative, even if the patient has Lyme rashes all over them, it will be hard to get any insurance company to pay for treatment. They will merely say, "Hey, the C6 Elisa test is negative so we reject your care."
Dr. James L. Schaller
Infectious Immunology. 1998 Aug;66(8):3689-97.
Erratum in: Infect Immun 1999 Jan;67(1):468.
The Lyme disease agent, Borrelia burgdorferi, is able to persistently infect humans and animals for months or years in the presence of an active immune response. It is not known how the organisms survive immune attack in the mammalian host.
My insert: Different research shows that Lyme goes to brain in under a month and starts to change itself to hide from your antibodies in the first weeks of infection.
vlsE, a gene localized near one end of linear plasmid lp28-1 and encoding a surface-exposed lipoprotein in B. burgdorferi B31, was shown recently to undergo extensive genetic and antigenic variation within 28 days of initial infection in C3H/HeN mice. In this study, we examined the kinetics of vlsE sequence variation in C3H/HeN mice at 4, 7, 14, 21, and 28 days and at 7 and 12 months postinfection.
Kinetics and in vivo induction of genetic variation of vlsE in Borrelia burgdorferi. Zhang JR, Norris SJ.
Department of Pathology and Laboratory Medicine and Department of Microbiology and Molecular Genetics, University of Texas Medical School at Houston, Houston, Texas 77030, USA.