Tag: diagnostic tests
Trump administration announces some COVID-19 tests can skip FDA review, providing new opportunities for dubious lab tests
The Trump administration unexpectedly announced that the FDA will no longer regulate some lab tests, including those for COVID-19. In addition to potentially allowing unreliable COVID tests on the market, the decision creates an opening for more bogus CAM tests.
COVID-19 Testing
Currently available tests for COVID-19 are imperfect but useful if used properly, with rapidly evolving research on new tests underway.
Experts slam CAM lab tests, call for better regulation
Experts review the evidence and find that common CAM lab tests have "little or no clinical benefit" and are "a potential risk to patient safety." Regulatory reform is urgently needed to protect the public.
Regulating CAM Aussie Style
CAM proponents view National Health Interview Surveys recording the supposed popularity of CAM, an amorphous conflation of anything from conventional medical advice to mythical methods, as an invitation to unleash even more unproven remedies on the public. My interpretation is quite different. I see the same figures as proof that we are doing too little to protect the public from pseudoscience. In...
Lyme Testing
I hate those oh hell moments. I was up way too late last night, but who can pass up the opportunity to see Patti Smith playing Horses (and more) for the 40th anniversary of the album. Only 44? Behind the Eagles? No way. I would nudge it up a few more spaces. Hard to believe I was 18 when that album came...
New FDA regulatory role threatens bogus diagnostic tests
The FDA regulates in vitro diagnostic devices (IVDs) as medical devices. IVDs analyze human samples, such as blood, saliva, tissue and urine. However, in the past, the agency did not use its authority to regulate what are known as “laboratory-developed tests” (LDTs), tests developed and performed at a single laboratory, with all samples sent to that particular lab for testing. Instead, it...
Lemons and Lyme: Bogus tests and dangerous treatments of the Lyme-literati
It’s that time of year when every day I can expect to see at least one patient with a concern about Lyme disease. In Lyme-endemic regions such as Western Massachusetts, where I practice pediatrics, summer brings a steady stream of children to my office with either the classic Lyme rash (erythema chronicum migrans, or ECM), an embedded tick, a history of a...
Why Doctors Order Too Many Tests
While cleaning out some old files, I was delighted to find an article I had clipped and saved 35 years ago: a “Sounding Boards” article from the January 25, 1979 issue of The New England Journal of Medicine. It was written by Joseph E. Hardison, MD, from the Emory University School of Medicine; it addresses the reasons doctors order unnecessary tests, and...