Whose interests is the FDA protecting? Not Lyme patients, apparently

[kickysnana]

On July 31, the FDA announced it would move forward with regulations to restrict cutting edge laboratory developed tests (LDTs), which have not required FDA approval before because they are not marketed to consumers. The new regulations would change that. Why should you care?

Because LDTs include the Lyme tests manufactured by IGeneX and Advanced Laboratory Services that many patients rely on for accurate diagnosis.

The FDA’s announcement came on the heels of a July 2014 letter sent by five U.S. Senators to the budget office, urging action on the FDA’s draft guidance, which has been under review for several years. The letter specifically calls out Lyme disease testing.

The problem is that the FDA approved tests for Lyme disease are notoriously insensitive and have been shown to miss more than 50% of Lyme disease cases. (Here) Currently, the FDA has approved 84 Lyme tests, which are produced by 28 companies. (List here) Approximately 90% of these are ELISA tests, which is the first test required under the CDC two-tiered lab test recommendations for Lyme disease. However, researchers have found that the ELISA is too insensitive to be used for screening: “Our data indicated that the sensitivity and specificity of the currently used tests for Lyme disease are not adequate to meet the two-tier test approach being recommended.”

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(Link)

[zazen]

1. the IDSA attack on Lyme patients and Lyme-literate docs is just bizarre

I was "fortunate" enough to be seropositive by CDC guidelines and still barely got treatment. The invalidation of Lyme and its symptoms is scandalous. And ironically it gives rise to quacks who do offer harmful treatments because we don't have enough research funding, insurance coverage, and legal cover for mainstream doctors, who are afraid to offer anything more than 3 weeks of antibiotics for fear of ostracism or, worse, multimillion lawsuits and loss of licensure (witness the case in NC).

[kickysnana]

2. All of that. I am so weary of this fight but...n/t

[lagomorph777]

3. The attack on Lyme patients will go down in history as one of the most monstrous crimes ever

By the way did you know you can see the Lyme spirochete in your own blood? Fuck the deliberately biased tests. All you need is a good microscope and a lancet of the type used by diabetics to draw blood to test their glucose level.