In a report made to Congress last week, federal investigators with the FDA have concluded that “Patients have been demonstrably harmed or may have been harmed by tests that did not meet FDA requirements.”
The report found that tens of thousands of people were put on unnecessary drugs, received unnecessary surgeries, and underwent abortions that were not needed.
They also concluded that patients were treated for diseases they did not have, while others had life-threatening diseases that were not detected.
The Obama administration and Congress are seeking regulatory powers to set stricter standards for medical testing. If they succeed, it would result in the most momentous change since 1988 for laboratory testing.
The report focused on 20 case studies of tests used to diagnose Lyme disease, heart disease, autism and cancer.
The FDA found many serious problems in the use of tests and resulting harm to patients.
One test used to detect ovarian cancer was used even though it has never shown to be effective and false-positive results lead to “unnecessary surgery to remove healthy ovaries.”
Other tests that inaccurately reported abnormalities in fetuses resulted in abortions.
Tests that purport to detect genetic variants that increase heart disease risk, a connection that has never been proven, were given to over 150,000 people, who were then prescribed cholesterol lowering drugs that may not have been needed.
Dr. Jeffery E. Shuren, director of the Center for Devices and Radiological Health at the FDA said, “The problems are more prevalent than people want to recognize, 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 further commented that the number of people affected by these inaccuracies is not known, because there are no reports that are collected for “adverse events” related to laboratory tests.
Victoria Steiner, spokeswoman for Genomic Health of Redwood City, California, who produces one of the tests cited by the FDA, said that “a wealth of evidence has supported the use of our test to help guide chemotherapy treatment decisions in more than 500,000 breast cancer patients to date.”
Commercial test kits, sold to multiple labs are subject to review by the FDA before going to market, and the manufacturers must report to the government any deaths or injuries related to the product. But tests produced and used within a single laboratory are not subject to the same rules, even though they may receive samples from many doctors throughout the country.
Consumer groups and the Democratic Party are supporting the Obama administration in its efforts to bring enforcement over the single laboratory tests through new legislation.
“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 Representative 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.”
The Republican Party is split between those who are skeptical of legislation and others who are open to the idea of instating legislation over the single laboratories.
Representative John Shimkus, Republican of Illinois was quoted as saying “This is a tough area for conservative Republicans who think that government is too big and costs too much, 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.
Representative Michael C. Burgess, Republican of Texas who is also a physician, said that the proposed legislation “could stifle medical innovation and open the door to federal regulation of the practice of medicine.”
Jayson S. Slotnik, consultant to drug and device companies also pitched in “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.”
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Release ID: 97601