WASHINGTON — Inaccurate and unreliable medical tests are prompting abortions, promoting unnecessary surgeries, putting tens of thousands of people on unneeded drugs and raising medical costs, the Food and Drug Administration has concluded.
Life-threatening diseases go undetected in some cases. In others, patients are treated for conditions they do not have.
“Patients have been demonstrably harmed or may have been harmed by tests that did not meet F.D.A. requirements,” federal investigators concluded in a report to Congress last week.
The findings come at a time when the use of laboratory-developed tests is booming, the Obama administration is seeking new regulatory powers and even Republicans in Congress are working on legislation to set stricter standards. The new standards, whether set by Congress or by the administration, would be the most significant change in the regulation of laboratories since 1988, lawyers say.
In 20 case studies — half involving tests used to diagnose and treat cancer, others focused on heart disease, autism and Lyme disease — the F.D.A. laid out a compendium of serious problems.
One blood test to help detect ovarian cancer was never shown to be effective, the report said, but was used anyway. False-positive tests may have led to “unnecessary surgery to remove healthy ovaries.”
Pregnant women have considered or had abortions because other tests inaccurately indicated abnormalities in the fetus.
Several tests now on the market detect a genetic variant that was once thought to increase the risk of heart disease, a link that has not been confirmed. Yet more than 150,000 people have been given these tests, the report said, and “many were likely over- or undertreated with statins,” cholesterol-lowering drugs, at a cost estimated at more than $2.4 billion.
“The problems are more prevalent than people want to recognize,” said Dr. Jeffrey E. Shuren, the director of the Center for Devices and Radiological Health at the F.D.A. “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.”
Dr. Shuren said officials did not know how many people might have been harmed, because information on “adverse events” associated with laboratory-developed tests is not systematically collected or reported — a gap that many in Congress and the administration want to close.
Inaccurate test results pose a significant threat to President Obama’s plan to develop treatments tailored to the genetic characteristics of individuals. Many of the new “personalized medicines” are used with a diagnostic test that identifies patients who are most likely to benefit, or to suffer serious side effects. If the tests are unreliable, the treatments could be ineffective.
(Click here to read the full article, written by Robert Pear, NY Times)