From Jenna's Lyme Blog
Perhaps it is too early for some to applaud the new blood culture to diagnose Lyme disease. In spite of the fact that all testing so far shows the test to be 100% accurate (barring contamination,) Medscape's Medical Journal recently published "Lyme Culture Test Causes Uproar" jumping on this test as if it is a plot to get people who have aches and pains, and think they have Lyme disease due to the internet, to spend money on a test that hasn't been adequately validated.
The MMJ's journalist, Janis C. Kelly, reports:
Physicians on all sides of the Lyme disease arena agree that a reliable culture test for active Borrelia infection would be a breakthrough. They differ on whether it is a good idea to market a blood test to consumers before it has been validated, peer-reviewed, published, reviewed by the FDA, or widely vetted by infectious disease experts with experience in Borrelia infections.
Joseph J. Burrascano Jr, MD, senior vice president of medical affairs and medical director for Advanced Research Corporation, voiced the complaint of many in the field that the 2-tier Lyme disease test approved and used by Centers for Disease Control and Prevention (CDC) relies on a serologic assay that can only indicate possible past exposure.
"What is very much needed is a direct test that can indicate whether living Borrelia are present in a patient," Dr. Burrascano said.
No Published Data
Soon after Advanced Laboratory Services' initial public announcements about the new culture test, emails and public statements attributed to Dr. Burrascano began appearing on Lyme-related Internet sites, including comments that the culture test was approximately 94% sensitive and 100% specific.
Dr. Burrascano told Medscape Medical News that the validity of the culture test was established using blood samples provided by physicians and that the identity of Borrelia was confirmed by its ability to grow in Borrelia-specific media, by its characteristic appearance on darkfield microscopy, by reacting to published Borrelia-specific polyclonal and monoclonal immunostains, by DNA polymerase chain reaction (PCR) at 2 different loci, and by direct DNA sequencing. These data are so far unpublished.
According to Dr. Burrascano, "All clinical samples turned out to be B burgdorferisensu stricto, which would be expected, as the clinical samples all came from patients who met the strict CDC surveillance case definition as having Lyme…. In addition, when a large number of normal controls were tested (well people), none of them had any positive cultures, meaning that there were no false-positives."
Dr. Burrascano said that a paper reporting the data has been submitted for publication and that "2 university-based research labs are each separately well on their way in validating the results of Advanced Labs."
The article puts a great emphasis on the cost of the test ($595) – obviously unaware how insignificant this is to individuals and sometimes entire families who are incapacitated with painful symptoms that doctors at numerous clinics and/or hospitals can't diagnose. This leaves the patient(s) feeling crazy, frustrated and desperate.
Where can we turn?
Dr. Burrascano is a trusted resource for those of us who have suffered or are currently suffering this nightmare of "shadow boxing", and is a source of hope and understanding at a time when the major medical establishments seem to want anyone who mentions "chronic Lyme disease" to be institutionalized for quackery.
This article is a great example.
For instance, Advanced Lab Services is vilified for using the following quote/fact in their marketing:
"The CDC estimates that in the USA there are more than 300,000 new cases each year and there may be as many as 4 million people currently infected."
This statistic doesn't surprise anyone who is currently involved in the research or treatment of chronic Lyme, however, challenged because this information is extrapolated from information published by the CDC in different places. And yet a representative from the CDC refutes the statement as untrue which causes conspiracy theorists to go bonkers! Perhaps the CDC needs better training on the issue of Lyme disease as they still maintain that the two-tier testing is to be used as supportive data for diagnosis – not as a diagnosis itself. However, the same government agency requires a positive ELISA and 5 positive bands on the western blot for a confirmed case of Lyme disease for their national monitoring of the epidemic.
Another glaring example of hypocrisy in this article comes from Gary Green, MD, infectious diseases chief and clinical director of the HIV Team & Travel Clinic at Kaiser Permanente in Santa Rosa, California. He is quoted as follows:
Dr. Green said, "The problem with a test that has not been validated and not been tested outside the source of invention is that we don't know whether it is at all accurate. Using an unvalidated test in modern medicine is dangerous and unethical."
"Unfortunately," Dr. Green said, "many people truly struggling with symptoms they think may be related to chronic Lyme disease understandably lose objectivity about a test like this to discern whether it is credible or valid. The medical community needs to be critical of itself and of the tests that we use."
Dr. Green added, "What I would say to a patient concerned about Lyme disease, struggling with a myriad of symptoms, is that we don't know if this test is valid. Until it is validated, it is irresponsible to use this in clinical medicine for the fear that you might be wrong in diagnosis. The harm is that perhaps there is a different and accurate etiology we are missing, and we get misled with a misdiagnosis from this unreliable test result. The patient may have objective disease or infection from another etiology that would not be identified if we hang our hat on this misinformation. It will derail diagnosis and treatment."
Where was Dr. Green when the two-tier testing protocol was developed? Where is the validation evidence that shows reliable diagnosis results for those? Mustn't we all agree that the two-tier protocol is dangerous, unethical and irresponsible to use a diagnostic tool because it, too, is not reliable?
What are the doctors afraid of?
They are afraid that this new test would prove all of the "false positives" in the ELISA and western blood assays are actually true positives. This would raise the number of Lyme infected people into the tens of millions of people if not more.
They are afraid that a reliable Lyme test would prove chronic Lyme disease not only exists, but that the powerful IDSA along with the self-righteous leaders of that great organization have been WRONG.
They are afraid of losing respect and perhaps even self-respect for treating suffering patients like idiots.
I will end with this true story that happened to me in Boston. After months of doxycycline my symptoms had only gotten worse after my initial crash after decades of mystery illnesses and several organs removed due to "unknown" infection.
One of the top infectious disease specialists at Lahey Clinic (also a professor at Harvard Medical School) told me he would not order a western blot because that would be fishing for a false positive. I asked how it would be false if I had all the symptoms for Lyme disease. He replied:
"Yes, you have all the symptoms for Lyme disease but I don't believe in chronic Lyme disease."
Look for my book "Scientific Evidence of Chronic Lyme" coming soon.
Jenna
Bob
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Bob Cowart
Email: bob@cowart.com
Phone: 510-540-6667
Psychotherapy: www.newtherapy.vpweb.com
Facebook: bcowart1
Twitter: @bobcowart
