ALS Lyme Culture Test Dangerous and Unethical

by lmatthews on January 29, 2013

dubious lyme disease test to watch out forAn unvalidated Lyme disease test being heavily marketed at those suspecting they have chronic Lyme disease is attracting attention from the medical establishment for potentially putting patients’ health at risk. Advanced Laboratory Services, Inc. launched their test in September 2011, offering it to the public at $595 and taking advantage of a US Food and Drug Administration loophole that allows laboratory-developed tests to be brought to market without any need for approval and, therefore, scientific, peer-reviewed research to validate claims of sensitivity and specificity. Many physicians are increasingly concerned that this company is taking advantage of the vulnerability of Lyme disease patients, especially as the test is not covered by insurance.

Is Premature Marketing of Lyme Disease Test Harmful?

The test in question is a culture which purports to assess the presence of active Borrelia burgdorferi in blood samples sent by patients. This kind of test would be extremely helpful to physicians but there are worries that it has been commercialized prematurely and without scientific data being published to support its validity. There is, as yet, no published research on the test, infectious disease experts have not had the chance to vet the assay and the marketing tactics of the company appear focused on discrediting existing tests and promoting in-house statistics citing 100% specificity.

A New Test for Lyme?

Joseph J. Burrascano Jr, MD, senior vice president of medical affairs and medical director for Advanced Research Corporation, is just one of many voicing opposition to the current state of Lyme disease testing. He notes that a test such as ALS’s would be extremely helpful as it could detect living Borrelia (Lyme disease bacteria), rather than indicating past exposure without being able to discern current infection. The two-tier testing required for a diagnosis of Lyme disease by the US Centers for Disease Control (CDC) has been found lacking on a number of occasions but has yet to be replaced by anything backed by scientific research.

No Research to Support Lyme Disease Test

Dr. Burrascano’s name has appeared on numerous forums citing a 94% sensitivity and 100% specificity for the Lyme culture test with no false positives. The validity of the test is said to have been demonstrated through the ability of samples 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. No corresponding data has been published, however, although Dr. Burrascano claims that a paper has been submitted for publication (he did not state which journal).


Unproven Tests Cited to Prove Other Unproven Tests

These methods of testing have previously been called into question by the medical establishment, especially in regards to PCR testing for Lyme disease, the use of unspecified media for culturing bacteria, and polyclonal immunostaining. Citing such tests as proof of validity becomes a circular argument that relies on patients not doing their own research prior to paying for the test. Many patients tired of going without a diagnosis for symptoms that seem to fit the profile for Lyme disease but for whom standard testing has failed to find evidence of infection may be done a disservice by this kind of marketed test. Encouraging the use of such a test is unethical and dangerous as patients and their physicians may give up looking for further diagnosis and apply inappropriate treatments or fail to treat the actual disease.

New York State Clamps Down on Dubious ‘Home-Brew’ Tests

These types of laboratory derived tests are being reviewed by the FDA in order to work on new guidance for regulation. New York State has already implemented extra regulatory requirements, meaning that this latest Lyme disease test is not available in that state. In previous years, the state conducted an investigation into the tests being done for Lyme disease by IGeneX, Inc. with results showing a failure to identify 2/20 positive samples, as well as incorrectly identifying 4/14 negative samples as positive. IGeneX went on to satisfy New York State’s requirements for the Lyme disease test.

The Dangers of the ALS Test

Advanced Laboratory Services relies on promoting the idea that there are considerably more people suffering from Lyme disease in the US than are accounted for in the official statistics from the CDC. While the CDC themselves admit that their figures for reported cases are likely only a fraction of the real numbers of people infected with Borrelia, it is important to remember that ALS, Inc. are encouraging use of an unsubstantiated Lyme disease test that could lead to dangerous treatment for a disease from which patients are not even suffering.

Can You Trust Lyme Disease Research?

Even when the company does publish research it is vital that patients understand that not all journals are equal as regards editorial ethics and stringency. Some journals have no peer-review process in place and are really little more more than marketing opportunities for companies like ALS. Indeed, there has been a review recently into such ‘Predatory’ Open-Access Scholarly Publishers who were disseminating information from at least one scientist found guilty of falsifying data, suppressing data and scientific misconduct in the field of AIDS research.

Costly Unvalidated Lyme Disease Test

Prior to any research being published in any journal to support the use of the test from ALS, the company continues to aggressively market the Lyme disease diagnostic at the price of $595 for “basic culture with polyclonal staining.” Additional costs are incurred for PCR with DNA sequencing, monoclonal immunostaining, and extended culture and all patients pay via credit card or cheque as there is no insurance plan that covers such an unvalidated test.

When Lyme Disease Tests are Appropriate

The American College of Physicians recommends that, to avoid the risk of false positives and harmful treatment, patients with less than a 20% likelihood, pretest, of having Lyme disease should not be tested. Non-specific ailments, including lethargy, aches and pains and headache without a report of erythema migrans (the Lyme disease rash), puts patients below this 20% threshold, meaning that their physician needs to consider all other options instead of simply placating a patient through use of unsubstantiated testing methods. In the long-run, this is the best option for patients as the true cause of their illness is more likely to be discovered and appropriate treatment started earlier than if the diagnostic process veers off towards an ephemeral diagnosis of Lyme disease based on unvalidated tests like the one from ALS.

Source: Medscape.


{ 5 comments… read them below or add one }

Sue Blanton February 2, 2013 at 2:27 pm

As a post-Lyme person, my sense of this is find an alternative provider who uses EAV testing to assure yourself that you have Lyme (if you do) and then follow some good, alternative therapy for it. Lots of us have done so, and we have recovered well and in a much shorter and surely much less expensive manner than the conventional program can do. Meanswhile, give the mice a break, as they don’t deserve to be carriers of some lab-designed pathogen, and we humans certainly don’t need them as carriers of severe disease. Would it be too much to ask that the FDA actually do their jobs, such as scientifically checking a new test, not just passing opinion without data? Would it be too much for medical journals to actually demand proof that scientific work has been done by labs that are NOT involved in the promotion of vaccines or drugs or therapies? If that’s just too hard, could all these pretenders get out of our way and let us find our own healing without them? My thanks to the alternative world who has experience on their sides.

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David Moyer February 2, 2013 at 11:47 pm

I wonder how much longer the “experts” will be able to maintain the fiction that Lyme disease is easy to treat and has absolutely nothing to do with certain cases of MS, Alzheimers, autism, heart block, and psychiatric illnesses, to mention just a few. You see, if the ALS test proves that the spirochetes grow in culture, as it did with my son, then true evidence based medicine will follow, not the findings of IDSA experts who are wedded to an obsolete paradigm for not just Lyme disease, but many other disease related to it. In my first book I argued that, based on repeated Western Blots my son’s Lyme played a significant role in his bipolar disorder. Since being diagnosed with the new test, he has been on three different antibiotics. In contrast to the previous 10 years, when he had his semiannual psychotic episodes, he has gone almost a year without an episode. He has a job and is married. Realizing that Lyme is one, not the only factor in his disorder, we are cautiously optimistic thanks to the ALS test and his treatment.

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Richard Snow February 18, 2013 at 2:32 pm

If my information is correct, every state but New York permits their residents to have this Lyme culture test. How do you explain that?

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Sue Sherratt February 19, 2013 at 11:15 pm

Sorry I don’t think this information is correct. I’ve just had a DNA PCR blood and urine test done at Australian Biologics for Borrelia and both came back positive. Cost less than $300.00. This gave me the result I was looking for and a diagnosis of Sarcoidosis since 1985 now allows me to get the treatment I need for Lyme Disease.

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Phil Goetz February 21, 2013 at 4:14 pm

Author: You write, “These methods of testing have previously been called into question by the medical establishment, especially in regards to PCR testing for Lyme disease … Citing such tests as proof of validity becomes a circular argument that relies on patients not doing their own research prior to paying for the test.”

No; what is circular is the existing literature which assumes the reliability of the CDC 2-tier testing, and uses it to “prove” the unreliability of synovial fluid testing, PCR, and even microscopic examination to detect Lyme. This is absurd. Auerwaerter finds patients who have Borrelia DNA in their synovial fluid despite failing the CDC test, and says it proves that PCR gives false positives.

PCR simply doesn’t give false positives unless your primers are designed incorrectly or you have contamination in the lab. It gives false negatives. But what happens in ALL the literature supporting the CDC 2-tier test is that the existence of false negatives in PCR testing is used to justify dismissing positive tests as false positives. A positive PCR test trumps a negative ELISA test any day.

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