Junk Science and the Need for Regulatory Oversight of Forensic Laboratory Developed Tests

Screen Shot 2014-02-25 at 1.06.55 PMNumerous “forensic” tests of unknown validity using urine, blood, hair, fingernails breath and saliva have been developed and brought to market as LDTs since the first one was introduced in 2003 when ASAM physician Dr. Gregory Skipper, then Medical Director of the Alabama Physicians Health Program, “convinced the initial lab in the USA, NMS near Philadelphia to start performing EtG testing.” With essentially no evidence base Skipper then claimed the alcohol biomarker “appeared to be 100 percent specific” in detecting covert use of alcohol for several days after ingestion based on a study he coauthored that involved a mere 35 forensic psychiatric inpatients in Germany, all male.

Disrupted Physician

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Laboratory Developed Tests

Questions about the accuracy and marketing of Laboratory Developed Tests (LDTs) have led to the current debate whether the U.S. Food and Drug Administration (FDA) should regulate a subset of diagnostic tests currently exempted from oversight. Designed to bring clinical tests to market that the costly FDA process would otherwise preclude, such as those for rare diseases, the LDT pathway bypasses Federal regulation and accountability.  Questions about the validity of these tests have raised concerns over patient safety and a call for oversight.  Among those asking for regulation are Massachusetts Senators Edward J. Markey and Elizabeth Warren.

Opponents of regulation argue the LDT  pathway enables new and pioneering tests to be developed quickly and improve patient care.  A recent viewpoint piece published in JAMA opposing regulation noted such advances have occurred “in large part because of the nimbleness of relatively small clinical and academic laboratories that can quickly respond to new…

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