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 FDA 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.
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In 20 case studies — half involving tests used to diagnose and treat cancer, others focused on heart disease, autism and Lyme disease — the FDA 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 under-treated 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 Jeffrey E. Shuren, director of the Center for Devices and Radiological Health at the FDA. “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.”
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 Barack Obama’s plan to develop treatments tailored to the genetic characteristics of individual patients. 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.
The maker of one of the tests cited by the FDA, Genomic Health of Redwood City, Calif., rejected the criticism. Victoria Steiner, a spokeswoman for the company, said that “a wealth of evidence has supported use of our test to help guide chemotherapy treatment decisions in more than 500,000 breast cancer patients to date.”
Diagnostic tests are now regulated differently depending on where they were developed and manufactured. Products that will be sold to multiple labs — “commercial test kits” — are typically subject to FDA review before they go on the market. Manufacturers are supposed to inform the government if they learn that their products may have contributed to a death or a serious injury, and they may have to notify the government if they recall defective products.
But for tests manufactured and used within a single laboratory, the agency has not actively enforced regulatory requirements, even though doctors around the country may submit samples to that lab for testing.
The Obama administration is moving to assert its enforcement authority over such laboratory-developed tests, saying they have become more complex, more widely used and more similar to commercial tests that the government has regulated for nearly 40 years.
Democrats and consumer groups have generally supported the efforts to regulate or legislate.
“Patients and their physicians should be able to trust the results of their tests, regardless of how or where a test is developed or performed,” said Rep. Frank Pallone Jr. of New Jersey, the senior Democrat on the House Energy and Commerce Committee. “It does not make sense to regulate tests differently based on who develops them.”
Republicans are divided between those who are willing to consider a larger federal role and others who are skeptical.
“This is a tough area for conservative Republicans who think that government is too big and costs too much,” said Rep. John Shimkus, an Illinois Republican. He indicated that he was willing to consider legislation because “the volume and complexity of these tests have grown exponentially,” and federal standards may be needed to ensure that the tests do what they are supposed to do.
But Rep. Michael C. Burgess, a Texas Republican who is a physician, expressed concern that the proposals “could stifle medical innovation and open the door to federal regulation of the practice of medicine.”
Jeffrey N. Gibbs, a Washington lawyer who represents medical device companies and laboratories, said he had seen a shift in the past six months: People once adamantly opposed to the regulation of laboratory-developed tests are now open to the idea.
“It is more likely that the FDA will have a role in regulating laboratory-developed tests as a result of either congressional action or a guidance document issued by the agency,” Gibbs said.
The American Clinical Laboratory Association, a trade group, contends that “the FDA lacks the statutory authority to regulate laboratory-developed tests.”
But Jayson S. Slotnik, a consultant to drug and device companies, said: “There will be more regulation, and it need not stunt innovation. The right regulation would separate good from bad tests and encourage use of the better ones.”