Consumer Health Digest #16-45

Your Weekly Update of News and Reviews
December 4, 2016

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.

FDA backs off important lab regulation. The FDA has announced that is postponing possible plans to regulate laboratory-developed tests (LDTs) until it it determines what might be acceptable to the incoming administration and Congress. [Firth S. FDA delays guidance on lab-developed tests. MedPage Today, Nov 21, 2016] (LDTs are tests designed, manufactured, and performed by a single CLIA-certified lab.) Although the FDA has the authority to regulate them, it has provided very little oversight of such tests. At present, LDTs do not have to be proven clinically valid. Many are valuable and evidence-based, but, as noted by attorney Jann Bellamy:

LDTs have become the perfect vehicle for pseudoscientific practitioners, like naturopathic "doctors," chiropractors, and "Lyme literate" and "integrative" physicians, who can test their patients for non-existent conditions and then proceed to "treat" them, sometimes with hundreds of dollars-worth of medically unnecessary dietary supplements. Where the practitioner lacks the legal authority to order lab tests (for example, in states where naturopaths are not licensed), he can simply tell the patient which direct-to-consumer test to order from a lab. Because bogus tests are not covered by insurance, the patient pays out of pocket, sometimes with a markup added by the practitioner. [Bellamy J. Dubious lab tests get reprieve after FDA backs off regulatory plan. Society for Science-Based Medicine Blog, Nov 27, 2016]

"Multiple chemical sensitivity" concepts failing in court. Quackwatch has indexed more than 70 cases in which courts have excluded proposed expert testimony that a plaintiff developed generalized chemical sensitivity from exposure to one or more environmental substances. There is now a clear judicial consensus that the diagnosis and concepts of multiple chemical sensitivity (MCS) have no scientific basis and that expert testimony based on such concepts should not be permitted. Some plaintiffs have attempted to get around this by labeling the patient's condition as something else, but courts have excluded such testimony as well. Attorneys faced with MCS-related cases may find the depositions and other documents in these cases helpful in defending against non-meritorious cases of alleged chemical injury. [Barrett S. Adverse court rulings related to clinical ecology theories and methodology. Quackwatch, Nov 23, 2016]

Trump's health-related actions arousing concerns. Many observers are worried that the incoming Administration will be less supportive of science-based health care and efforts to fight health-related frauds. A MarketWatch article expresses concerns about vaccination related to Trump's nominee for HHS Secretary. [Court M. The controversial medical association that counts Trump nominee Tom Price among its members. MarketWatch, Dec 2, 2016] A Fierce Health Care article wonders whether anti-fraud efforts will be decreased. [Sweeney E. Special Report: 4 ways Trump's win could affect the fight against healthcare fraud. Fierce Health Care, Nov 21, 2016]

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This page was posted on December 3, 2016.