Why FDA Lyme Disease Regulatory Change Should Concern Patients

Source: Lyme Disease.org
What’s so bad about requiring FDA approval for Lyme tests?
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…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.”
So FDA approval of Lyme tests does not equate with quality. In fact, to obtain FDA approval a lab test need only meet the low bar set by other FDA approved tests. That means if a company can afford to go through the process, it can introduce more lousy tests on the market..

  • It’s not about giving patients the best care and treatment; it’s about making things “fair” for multi-billion dollar corporations that provide faulty Lyme tests. Plus, the lack of competition also means that larger companies, whose tests are already approved, will have no incentive to improve them.
  • The regulatory change has been widely criticized for suppressing innovation and reducing patient access to care:
  • The American Medical Association was among the first to raise concerns, saying it believes the regulations add an additional layer of requirements which may result in patients “losing access to timely life-saving diagnostic services and hinder advancements in the practice of medicine.”

The Association for Molecular Pathology (AMP) said the regulations would “harm patients by reducing access, decreasing innovation, and substantially raising the costs of essential diagnostic testing.” AMP also noted that LDPs are “often the standard-of-care, the highest quality test available, and at times, the only available testing option.”
Twenty-three laboratory directors and pathologists from academic centers including Harvard, Duke, and the University of Utah, have gone on record warning FDA regulation will stymie the growth of personalized medicine and the ability of labs to keep pace with the changing face of disease…
Lyme patients have been railing against the poor quality of Lyme tests for years. So why aren’t better tests on the market? Blame the vested lab interests that currently control FDA Lyme testing. Among the 28 companies with FDA approved tests, at least 25% have ties to the key IDSA researchers who developed the IDSA Lyme guidelines…
The public comment period for the proposed regulation will open in October. We hope you have your pen handy.

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