Amid increased concerns about misdiagnoses in healthcare, unreliable, inaccurate medical testing is also a major obstacle to patient safety, hiking unnecessary medical and drug expenses as well as prompting unneeded medical procedures, according to a new report from the Food and Drug Administration (FDA).
FDA investigators conducted 20 case studies involving tests used for cancer, autism, Lyme disease and heart disease and found wide-ranging, systemic problems. For example, a blood test for ovarian cancer was used despite no evidence it was effective, increasing the risk of false positives and subsequent unnecessary surgery. Similarly, inaccurate test results indicating fetal abnormalities have led women to get abortions, according to the report, while more than 150,000 people given tests for a genetic variant that possibly increases heart disease risk were likely over- or undertreated with cholesterol-lowering drugs.
Tracking these problems is also difficult, because health agencies do not collect or report information on adverse events caused by lab-developed tests the way they do for hospital medical errors.
In addition to threatening patient safety, these problems may also be a major stumbling block for President Barack Obama's Precision Medicine Initiative, which relies heavily on personalizing healthcare around the results of diagnostic tests, according to the New York Times. Unlike "commercial" tests, which are subject to FDA review before they can be sold to labs, tests manufactured for use within a single laboratory come under far less regulatory scrutiny. Indeed, all the tests the FDA studied met the minimum requirements for the Clinical Laboratory Improvement Amendments, according to an announcement from the agency.
As the use of laboratory testing increases, proposals to increase regulatory power over manufacturers has rare bipartisan support, and new standards could represent the most significant change in the regulatory framework for laboratories in nearly 30 years, according to the Times.
"The problems are more prevalent than people want to recognize," Jeffrey E. Shuren, M.D., the director of the Center for Devices and Radiological Health at the FDA, told the Times. "Doctors and patients rely on these tests to make well-informed healthcare decisions. If they get inaccurate results, they can make the wrong decisions, and people get hurt as a result."