Promise and Peril in Diagnostics

Tuesday, August 16, 2011

"There are many areas of medicine where not testing, not imaging, and not treating actually result in better health outcomes"
—Dr. Rita Redberg

"Unless you do the imaging, you are really playing Russian roulette with your life"
—Dr. Robert Agaston

Yesterday, Newsweek ran a cover story that stated (quite garishly) that refusing medical testing could be essential to your survival. As if in rebuttal, CNN ran a story today asserting that celebrity doctors and super-cool imaging tests may be able to eliminate heart disease completely.

Nothing grabs eyeballs like a good guy / bad guy narrative, but when you put these stories side-by-side, it's not difficult to understand why we have such a conflicted view of the regulatory process.

FDA, it would appear, is either failing to protect us from the talons of predatory medicine... or is the main obstruction preventing the South Beach Diet doc from curing heart disease. Either way, they sure are getting it wrong.

The challenges and risks associated with screening tests are well-known. We've seen this with PSA and many types of imaging tests. Tests that appear to show something do not necessarily lead to improved outcomes. More disturbingly, tests that indicate risky interventions may do more harm than good.

But is any of this really about good guys and bad guys? Can we possibly get past the doctors-are-evil or doctors-as-saviors tropes to see what's actually going on?

There's a glimpse of a more nuanced view in the Newsweek story. Despite the eye-rolling graphics, the article makes several good points. in particular, it puts a finger on one of the subtler issues: there are many pressures and temptations to use tests for purposes and populations outside of those which have been clinically proven. We all understand that this is a problem, but almost can't seem to help ourselves. There are lives to be saved, reputations to be built and money to be made. None of these factors argue very well for caution, patience or prudence.

At the same time, the lurid graphics in Newsweek illustrate perfectly what happens when we fail to rein ourselves in: we erode confidence. None of the legit players in the medical marketplace benefit from that.

So how do you harness the creative potential of scientific and commercial advancement while maintaining the well-being and confidence of patients?

This, in a nutshell, is the exact problem FDA was created to solve. None of us enjoy being held to high, rigorous standards but we are all better off for having a well-regulated marketplace available.

We'd do well to keep that in mind as we bring our cutting-edge screening tests in for agency review. It can be surprising, sometimes, that products with huge promise don't get a warmer reception. The problem isn't that FDA fails to see the promise, it's that they also see the peril. Their job, ultimately, is to keep the dream of eliminating disease linked to an imperative to show results. Doing that is our best hope for sustaining a marketplace where such dreams truly can become reality.

Tags: 510(k), Advertising and Promotion, FDA, IVD, Industry, Policy, RUO

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