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Monday, March 2, 2009

Alan G. Barbour, M.D: In his own words

Dr. Barbour wrote a wonderful little book intended for the lay public in 1996.
The Book is titled: Lyme Disease, The Cause, the Cure, the Controversy.

The book is full of interesting and sometimes quite detailed information. Dr. Barbour does a wonderful job of explaining the ELISA test, its methodology and "Pitfalls."

The sensitivity and specificity of the test is claimed to be 94 to 98%. But the predictive value of the test is consider "much lower," when the history and physical show that the chance of having Lyme disease is low. This is a critical point. First of all, why would someone perform the test if the likelihood of Lyme disease was low?
The sensitivity and specificity numbers are based on what LLMDS would call a narrow notion of the symptoms and signs associated with Lyme disease. The thinking at that time, which has persisted to this day in IDSA quarters, is that Lyme disease presents with certain well defined syndromes. These include the EM rash,inflammatory arthritis- typically a large joint, Bell's Palsy, acute meningitis and typical cardiac disease such as atrioventricular block. In this "old" thinking, symptoms such as fatigue, generalized pains and brain fog are not part of the equation. These are the classic symptoms that most LLMDS consider typical of Lyme disease.

The ELISA test gives a reaction on a scale. He admits (pages 96,97) that the positive cutoff point is set by "someone, or more likely a committee." This means that a group of experts picked a cutoff point for a positive reaction based on the best information available to the group at the time.

Here are his important words: "How is the cutoff point set? Selecting a cutoff point would be simple if people without Lyme disease showed no reactivity in the assay...But this is not what has been found. On the contrary, a substantial number of healthy people or 'negative controls,' as they are known, have had detectable antibodies that bound to spirochete parts." ...These people seldom had titers or color values which were as high as those of Lyme disease patients, but the two groups did overlap. There was no value below which all control sera fell and which all Lyme disease sera fell."

What he is clearly saying is that patients without Lyme disease and those with Lyme disease could react similarly on the ELISA assay. The people without "Lyme disease" were a healthy control group. Remember, his definition of Lyme disease was quite narrow. Control subjects with fatigue and brain fog could have been included in the "healthy" control group.

He cites 3 reasons for what he considers false positive results: Infection with something that causes cross reactivity, like syphilis; someone could have "sticky" antibodies, as seen in autoimmune disorders; or test subjects may have actually been exposed to Lyme disease in the past. Question: How can previous exposure to Lyme disease be considered a false positive? The science now informs us that Lyme is a persistent infection once it becomes established in the host.

It seems to me that it is relatively easy to rule out the first two items. therefore, a positive ELISA test should indicate exposure to Lyme disease.
As explained above, the cutoff for a positive ELISA was set high based on prevailing beliefs. If a patient has a positive ELISA it would seem to prove Bb exposure.

According to CDC/IDSA rules the positive ELISA must be followed by a Western Blot. Based on what is described above this does not seem reasonable. The WB bands reported are based on the CDC surveillance case definition and have not been validated as a diagnostic test. We know that critical bands such as the 31 and 34 bands have been omitted AND that only 3 IgM bands are reported.
Based on what logic can this test be used to confirm a positive ELISA test? The ELISA tests we are told have many false positives. Dr. Barbour, who was there when the ELISA test for Lyme disease was developed seems to be saying, that in the main, false positive ELISA results indicate previous exposure to Lyme disease.
To make matters worse, labs no longer report the value of the ELISA index. If a physician were to reasonably infer that the cut off for a positive test was set to high, the physician is no longer afforded the ability to apply his clinical judgment to assess the significance of a particular ELISA value.

On page 170, Dr. Barbour discusses the controversy of post-Lyme disease versus chronic Lyme disease. He does not deny that chronic Lyme disease exists. He relates this to "late infection." He states: "The difference between the two disorders is that most patients with late infection, still respond, at least partially, to antibiotic therapy, while patients with the post-infection syndrome usually do not."

Dr. Barbour's writing here would appear to support the ILADS approach: "If a patient improves with continued antibiotic therapy, the patient has chronic Lyme disease."

After all, is this not the basic issue upon which ILADS and IDSA disagree? He states that studies sponsored by the NIH should further clarify the issue. Three studies have now been done, yet, the waters remain muddy.

To be fair to Dr. Barbour, he discounts the correlation of "atypical symptoms": fatigue, generalized aches and pains, sleep problems, brain fog and others with Lyme disease. The paradigm described in the book states that such symptoms are likely not due to chronic Lyme disease. Although, he leaves open the door for post-Lyme correlating with such symptoms.

He wrote that other infections such as HIV should be considered. He wrote that patients may have chronic fatigue syndrome, fibromyalgia or a psychiatric disorder.

He does have an interesting chart in which he compares the features of Post-Lyme disease with Fibromyalgia and Chronic fatigue syndrome. He considers that the following symptoms may be found in all three disorders: Fatigue unrelieved by rest, activity less than 50% normal, unrefreshing sleep, difficulty concentrating, musculoskeletal pain and headache. If current science shows that Lyme persists in the host then would it not be reasonable to at least consider the possibility that post-Lyme really is chronic Lyme?

He further posits the main IDSA argument: Symptoms are subjective- there are no objective measurements which prove that Lyme is the cause for chronic symptoms. At any rate it is assumed that persistent symptoms are largely the product of a post-infection syndrome.

He posits that Lyme is not the cause of neurological disorder such as MS and ALS.

He says that Lyme is not a cause of autoimmune disease such as RA and SLE. He does admit that it has been postulated that infections may trigger such disorders but states there is no objective evidence that treatment is effective.

I believe that Dr. Barbour's statements reflect the ongoing position posited by the CDC and ILADS. Perhaps some updating of these views should be considered.

We certainly know that Lyme disease, if not the cause of MS and ALS, can mimic these disease states.

We know that patients with "autoimmune," inflammatory arthritis have shown positive PCR tests of synovial fluid and tissues for Lyme and Mycoplasms. We know that the same patients have improved with antibiotic therapies. Some patients show positive tests for RA and SLE which improve with antibiotic therapy.

Patients DO GET BETTER WITH CONTINUED ANTIBIOTICS. Shouldn't chronic Lyme rather than post-Lyme be considered based on Dr. Barbour's own comments?
There IS objective evidence in chronic Lyme patients. They have fevers and chills. They have Herxheimer reactions with antibiotic therapy and then seroconvert on ELISA and Western Blot tests. They test positive for co-infections. They have abnormal physical exams which revert to normal after therapy. They have abnormal lab studies, outside of Lyme per say. They have organisms in the blood which have yet to be identified. They have low CD57 counts. They have changes in vitamin D levels. They have changes in vitamin B12 and folic acid. They have abnormalities seen in the- CBC, sed rate, CRP, comlement levels and other lab parameters. They have abnormal MRI and SPECT brain scans.

There is at least one NIH sponsored clinical study which supports the existence of chronic Lyme disease. The two other studies are controversial and can be interpreted in different ways.

This book is full of interesting facts and contradictions. It reflects a mainstream medical position which remains unchanged for years, and which continues to ignore information which undercuts its primary tenants.

The ELISA and Western Blot tests are clearly flawed, as evinced in this book, yet the CDC's has solidified its position regarding the two tiered Lyme test. On what basis?

An oft quoted adage in medicine is: "You only diagnose that which you know."
One must always keep an open mind because in a field like medicine, there will always be much that one does not know.


MJ said...

The chronic fatigue syndrome, the sleeping disorder, the fibromyalgia, the brain fog, the multi-pains and all the others are not considered Lyme but what? Post-Lyme? ok, great; is it a name or it means no treatment after?!
They want to say these symptoms come from what, where? They say it is just a response after having an infection? great, a post infection, and because of this consideration, being a post- syndrome, all these painful, hard symptoms should not be treated or must not be treated or it is not "necessary" to treat them? which word they want to use?
No need to treat; cannot be treated, don't want to treat?

They should clearly state it in their guidelines: "patients with these multi-symptoms, who we consider have post-Lyme should be left to die in pain"!
Hope the ethics and God judge them because they are not willing to consider their humongous mistake, ignoring the call of this post, and the voice of this Doctor
-Montgomery Doctor- who clearly demonstrates over and over again the different aspects of this terrible disease, and who calls for help to patients like me who suffer without receiving appropriate help due to the negligence of these who doesn't want to hear nor help.

Why they ignore your voice Doctor, that it is our voice? They do not want to hear it, why?
Why the denial? Why the negligence?
Why arguing words instead of presenting valuable evidence with medical scientific demonstrated cases and reasons?
Maybe it might cost money or are there other considerations different from the medical health area?
As a human being, as a patient, I think this is very unfair and hope the truth arises soon; specially for the ones who are denied treatment based on ignorance and what ever other political or economical reasons - plus medical egos!!
Thank you for letting me share with you; hope I might be of some help for all one day too!
May God help us!

Pseudonymity said...

From the post:

The sensitivity and specificity of the test is claimed to be 94 to 98%. But the predictive value of the test is consider "much lower," when the history and physical show that the chance of having Lyme disease is low.

Let me see if I understand this - during blinded trails, both the sensitivity and specificity of ELISA was above 90%. In other words, I test 100 samples without any patient history, and the ELISA gets the result right more than 9 times out of 10.

The clinical predictive value is lower - meaning that the test does not really line up with Dr. Barbour knows to be Lyme disease.

Is my interpretation wrong, or is he claiming that since his findings do not line up with ELISA results, that the sensitivity and specificity results obtained from controlled experiments is wrong?

Is that supposed to be some type of Jedi mind trick?

Michele said...

I had strong 31 & 34 bands. What do you mean these critical bands have been deleted? Good info today out of TX Health Science Center of San Antonio written in the on-line proceedings of the National Academy of Sciences. Dallas, Houston, Texas A & M Health Science Centers are working together to find the pieces and they are backtracking a little but at least not fighting. I plan to contact friends there to see what's up. A lot of good research is being done there with little to no fighting. Since different strains of Bb, babesia, bart, etc exist in different areas of the country how will a doctor know what he/she is really treating? Maybe the person vacationed out west a few months ago. Doctors have always focused on my tick bites and I do have Lyme but we also go to many misquito breeding grounds and clean them up and get a few bites; other insects, dirt, dead fish and turtles. We are around mammals, all kinds of small rodents, bears, foxes and other. Maybe the focus should be broadened as with others out in nature a lot.
What was CDC "survelience" criteria meant for? A benchmark?