A new report from the Food and Drug Administration concludes that some medical tests are doing more harm than good.
A number of unreliable tests are reporting false positives with disastrous results. Many women have had their ovaries unnecessarily removed as a result of a flawed test for ovarian cancer. Tests have reported nonexistent fetal abnormalities that have led other women to have abortions. An unproven test that claims to identify a link between a certain genetic variant and heart disease has likely led to many people being prescribed drugs to lower cholesterol.
"The problems are more prevalent than people want to recognize," Dr. Jeffrey E. Shuren, the director of the Center for Devices and Radiological Health at the FDA, told the New York Times. "Doctors and patients rely on these tests to make well-informed health care decisions. If they get inaccurate results, they can make the wrong decisions, and people get hurt as a result."
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The FDA is marshalling the report as evidence that the agency needs to regulate laboratory-developed tests. In a blog post arguing for regulation on the FDA website, Peter Lurie, the agency's associate commissioner for public health strategy and analysis, said that it chose to exempt LDTs from regulations imposed on other medical devices because "they were relatively simple tests generally confined to local labs, and often used for rare conditions."
"But times have changed," he added. "LDTs have increased in complexity and availability and are now frequently used to diagnose common, serious medical conditions, including cancer and heart disease, with potentially greater impact on patients."
The FDA is already finding eager allies among Democrats. But many Republicans are hesitant to impose restrictions on the businesses in the pharmaceutical field responsible for the tests.
"This is a tough area for conservative Republicans who think that government is too big and costs too much," Representative John Shimkus, R-Illinois, told the Times. He nevertheless added that he was open to exploring more regulation, given the complexity of the burgeoning industry and its serious implications for patients.
Expect resistance, however, from the medical device industry. The American Clinical Laboratory Association responded to the news by saying that the FDA "lacks the statutory authority to regulate laboratory-developed tests."
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