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FDA Says Some Lyme Disease Tests Are Dangerous
Sunday 29 November 2015
FDA Says Some Lyme Tests are Dangerous - Will Start Regulating Them - Major Changes Expected
Last November the FDA [U.S. Food and Drug Administration] stated it was going to start regulating what it calls "Laboratory Developed Tests". These are tests that are developed by and for single laboratories (often genomic firms) but have not been subjected to regulatory approval. At the time the FDA's regulation was created these tests were rare but with the development of genomic testing thousands have been developed. Many labs do subject their tests to stringent internal and/or independent testing but not all do.
That announcement was met by fierce opposition by industry and some academics.They stated the new regulations - which will likely make tests more expensive to develop - would stifle innovation and hurt patients.
The FDA, however, believes some of these tests are doing more harm than good.
In some cases, due to false-positive tests, patients were told they have conditions they do not really have, causing unnecessary distress and resulting in unneeded treatment. In other cases, the LDTs were prone to false-negative results, in which patients’ life-threatening diseases went undetected. As a result, patients failed to receive effective treatments.
Lyme Disease Tests Prominently Featured
Lyme disease tests were featured front and center in a recent FDA report highlighting 20 offending lab tests. The FDA and Lyme disease labs and some Lyme physicians have been butting heads for years. The CDC has gone so far as to produce video's featuring patients misdiagnosed with Lyme disease who were later found to have something else. (See below).
In a report titled "Can You Trust Lyme Disease Tests?", the New England Center for Investigative Reporting found, however, that thousands of people were being assessed for Lyme disease every year using unvalidated and inaccurate tests.
It noted that New York State - the only state that attempts to independently verify the accuracy of the tests - is not allowing seven labs to run Lyme disease tests there.
IGeneX, a large Lyme disease testing lab, has reportedly attempted three times to get New York State approval and has been denied all three times because of insufficient documentation. Igenex offers a Western Blot and urine tests and allows fewer bands be present for a Lyme Diagnosis than the CDC.
Common in the Northeast
The FDA asserts that a diagnosis of Lyme disease should be made based on a history of tick exposure, symptoms and two positive tests: a positive initial enzyme-linked immunosorbent assay test followed by a confirmatory Western Blot test. One FDA official stated it was very important that both tests be done.
The Western Blot tests are not affected by the new oversight; the FDA has OK-ed over 80 Western Blot tests by different laboratories for Lyme.
The Western Blot test identifies IgM and IgG antibodies against several different B. burgdorferi antigens. Because the test can pick up antibodies other than the Lyme bacteria everyone will probably test positive to at last one band. The FDA requires that at least 5 of 10 bands on the IgG assay and 2 of 3 bands on the IgM assay be positive for a Lyme diagnosis.
Particularly in the northeast, Lyme is common. Doctors using FDA recommended Western Blot Tests make 300,000 new diagnoses every year. Testing is common as well. Over 3 million Western Blot tests costing over 400 million dollars are done every year.
Unvalidated Lyme Tests
The FDA apparently has little good to say about the rest of the Lyme Disease tests. It asserts that many urine, blood and culture tests for Lyme disease are not accurate and are causing harm.
"A falsely positive diagnosis of Lyme disease can lead to patients experiencing harmful side effects without clinical benefit, an increase in the risk of creating infectious organisms resistant to the antibiotics used to treat Lyme disease, and delay in the diagnosis of a patient’s true underlying condition."
The FDA came down particularly hard on urine tests. Between 50 - 70,000 urine tests for Lyme were run in 2005. It stated that an independent evaluation on healthy subjects gave false positives 50% of the time. Sometimes running the same blood sample again gave different results. It concluded that
"at least half of all test results were incorrect or uninterpretable, and that this test should not be used for Lyme disease detection."
Similar findings occur for some blood tests and a culture test. The FDA noted two couples were awarded $30 milllion in damages after they received months of antibiotic and other treatments.
In April 2014 the FDA concluded that false-positive results caused by laboratory contamination and the potential for misdiagnosis" made a culture test unworkable as well.
The FDA estimated that the average cost of a false-positive diagnosis was about $1,220 per patient.
Some patients who tested negative on FDA approved tests but positive on unapproved test and then improved on antibiotics are upset. The Center for Investigative Reporting report noted that the FDA test is not particularly accurate in the early stages of the illness but is quite accurate after more time has passed. The FDA acknowledges there are problems with the test but states that no better tests have appeared. For patients with a Lyme rash but without a positive blood test it recommends immediate antibiotic treatment.
With the FDA featuring Lyme prominently in its report expect the FDA to require large Lyme labs to undergo stringent testing and validation procedures. If they don't pass the FDA will apparently not allow them to market their tests anywhere in the U.S. It's about to get very interesting in the Lyme testing world.
CDC Video - When Lyme Disease Isn't
The above, with comments, originally appeared here.
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