Bad diagnosis: FDA backs down from plan to regulate tests.

• Author: Nash, Stephen

An old high school friend of mine--call him Craig--recently took a test for cancer, after which he and his doctor had to decide whether he should undergo radical surgery. The evidence for the test's reliability might have been stronger, and the decision clearer, had the federal Food and Drug Administration known more about this diagnostic tool. But that isn't likely to happen anytime soon.

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The tool in question belongs to a category known as laboratory developed tests, or LDTs. These are used to diagnose and guide treatment for a range of conditions, from Lyme disease fetal chromosomal defects, and autism spectrum disorder, to ovarian, cervical, breast, and prostate cancers. The FDA, which since its creation in 1906 has been largely responsible for pulling medical remedies out of the snake-oil era, has tried for decades to establish oversight for LDTs in order to verify claims about their safety and effectiveness.

At one time, these tests were a minor part of medical practice; today, thanks to recent advances in genomics and other molecular techniques, thousands of LDTs are available, with more coming on the market each day. But the FDA, after identifying problems with the claims made about these tests, has taken a giant step back from imposing stricter regulations.

In November, shortly after the election of Donald Trump, the agency announced that it was delaying action on new regulatory guidelines for LDTs, which had been in the works for several years. It said it might take some other action, some other time.

"FDA believes that patients and health-care providers need accurate, reliable, and clinically valid tests to make good health care decisions--inaccurate or false test results can harm individual patients," agency press officer Tara Goodin said in November. "We have been working to develop a new oversight policy for laboratory developed tests, one that balances patient protection with continued access and innovation, and realize just how important it is that we continue to work with stakeholders, our new Administration, and Congress to get our approach right."

LDTs hold great promise. But without independent, careful validation of their safety and effectiveness--ideally by folks who don't have a financial stake in their use--neither doctors nor patients can distinguish marketing hype from real evidence.

You might think scrutinizing such tests is the province of scientists free of political pressure and conflicts of interest. You'd be wrong. Billions of dollars in Big Pharma revenue hang in the balance, and "stakeholder processes" can substitute for science at times. "It's a very politicized issue and there are a lot of players," Dr. Elizabeth Mansfield, the FDA's director for personalized medicine and molecular genetics, told me not long before the agency's stand-down.

In support of its proposal to impose new regulations, the FDA identified twenty examples of LDTs on the market that "may have caused or have caused actual harm to patients. In some cases, due to false-positive tests, patients were told they have conditions they do not really have," the agency's November 2015 report states, "causing unnecessary distress and resulting in unneeded treatment. In other cases, the LDTs were prone...