Consumer Health Digest #15-49

Your Weekly Update of News and Reviews
December 13, 2015

Consumer Health Digest is a free weekly e-mail newsletter edited by Stephen Barrett, M.D., with help from William M. London, Ed.D., M.P.H. It summarizes scientific reports; legislative developments; enforcement actions; news reports; Web site evaluations; recommended and nonrecommended books; and other information relevant to consumer protection and consumer decision-making.

Urine mold test debunked. Quackwatch has published a major investigative report on urine mycotoxin testing performed by RealTime Laboratories (RTL), of Carrollton, Texas. RTL claims that its Mycotoxin Panel test is "unique in its ability to determine if a patient's health problems are associated with toxic mold exposure." However, the prevailing medical opinion is that urine mycotoxin testing has no valid medical use. [Barrett S. A skeptical view of RealTime Laboratories and its president, Dennis Hooper, M.D. Quackwatch, December 13, 2015] A recent NIOSH report concluded that "using unvalidated laboratory tests to diagnose work-related illness can lead to misinformation and fear in the workplace; incorrect diagnoses; unnecessary, inappropriate, and potentially harmful medical interventions; and unnecessary or inappropriate environmental and occupational evaluations." [Kawamoto M, Page M. Notes from the field: Use of unvalidated urine mycotoxin tests for the clinical diagnosis of illness—United States, 2014. MMWR 64:157-158, 2015]

FDA concerned about laboratory-developed tests. The U.S. Food and Drug Administration has developed considerable concern about laboratory-developed tests (LDTs), which it defines as tests performed only by the laboratories that develop them. CLIA, the primary laboratory regulator, examines how tests are performed, but it does not consider how their results are interpreted. Widely used diagnostic tests require FDA clearance or approval, but the agency has not attempted to regulate LDTs. During the past two years, however, the agency has expressed concern about LDTs that are used to guide treatment decisions. In 2014, it drafted a regulatory framework that includes pre-market review. [Laboratory developed tests. FDA Web site, Nov 17, 2015] In November 2015, it reported on twenty LDTs, noting that some of them can cause patients to undergo unnecessary treatments and potentially delay diagnosis of their true condition. [FDA Office of Health Strategy and Analysis. The public health evidence for FDA oversight of laboratory developed tests: 20 case studies. Nov 16, 2015] The report's section on "tests linked to treatments based on disproven scientific concepts" included heavy metal chelation challenge testing (also called "provoked" testing) in which a chelating agent is administered before the urine specimen is collected and the test results are compared to the levels found in non-provoked specimens. RealTime Laboratories' Urine Mycotoxin Panel was not mentioned, but it fits the selection criteria for the FDA report. Chelation Watch explains why provoked testing for heavy metals is improper.

FTC sues weight-loss marketers who attempted to intimidate critics. The Federal Trade Commission is pursuing Roca Labs, Inc.; Roca Labs Nutraceutical USA, Inc.; and their principals who marketed alleged weight-loss supplements and threatened to enforce "gag clause" provisions to stop purchasers from posting negative reviews. [FTC sues marketers who used "gag clauses," monetary threats, and lawsuits to stop negative consumer reviews for unproven weight-loss products. FTC news release, Sept 28, 2015] According to the FTC's complaint, the defendants:

In October, a federal court issued a preliminary injunction ordering the defendants to stop the actions identified in the FTC's complaint.

Braverman convicted of attempted larceny. A New York Superior Court judge has found Eric R. Braverman, M.D. guilty of attempted petty larceny (a misdemeanor) and sentenced him to 15 days in jail plus a $175 fine. Braverman, who operates a high-priced "brain health" clinic in New York City, was arrested in January 2014 for allegedly trying to steal confidential documents from a courtroom during a custody battle with his wife. Quackwatch has a lengthy report on Braverman's questionable medical activities.

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This page was revised on May 20, 2017.