The Need for Regulatory Oversight of Laboratory Developed Tests (LDTs) in Drug and Alcohol Testing: Junk Science is Junk Science and the Silence is Deafening.

The debate focused on the reliability and validity of a number of clinical tests currently marketed with unverified claims of accuracy such as those used for prenatal screening and Lyme disease.  Notably absent from the discussions are the vast number of  Laboratory Developed Tests tests being used for “forensic” drug and alcohol testing with the current FDA draft guidance stating simply:

At this time, FDA will continue to defer oversight of the use of these tests in the forensics (law enforcement) setting to the existing system of legal controls, such as the rules of evidence in judicial proceedings and other protections afforded through the judicial process.”

The debate focused on the unreliability of lab tests such as those for Lyme disease but simply glossed over forensic drug and alcohol tests.  Let’s think about this critically for a moment as a false positive  test for Lyme disease can  result in unneeded treatment and costs but a false drug or alcohol test can result in consequences far more grave such as loss of a child,  loss of a professional license, and imprisonment.  The results of a positive forensic test for drugs can be far reaching and permanent. So how did this happen?

The answer is simple.  Money and profit.    Lobbying groups such as the Drug and Alcohol Testing Industry Association (DATIA)  ( which represents more than  1,200 companies involved in the drug and alcohol testing industry simply said “How dare you interfere with our war on drugs?” and the tests were off the table.  The DATIA even employs its own DC based lobbying firm, Washington Policy Associates, and money talks.   How dare anyone interfere with the profiteering ambitions to utilize junk-science in the mainstream population as specifically and explicitly spelled out in  Robert Dupont’s 2012   keynote speech before the Drug and Alcohol Testing Industry Association and in the American Society of Addiction Medicine’s  (ASAM’s ) White Paper on Drug Testing. These two documents should be required reading for anyone interested in civil liberties and fundamental freedoms. That they have been disregarded by most is incomprehensible and worthy of exploration.  These documents both propose random mandatory and unnecessary and insurance paid drug-testing utilizing the medical profession (pediatricians to obstetricians to geriatricians) as a drug-testing collection agency using not only urine samples  but also blood , oral fluid (saliva), hair, nails, sweat and breath.” It is all spelled out concisely-just read the papers.

Source: The Need for Regulatory Oversight of Laboratory Developed Tests (LDTs) in Drug and Alcohol Testing: Junk Science is Junk Science and the Silence is Deafening.

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