surround biomarkers, and the interfaces they have to other measurements in medicine.”

The committee posed the following questions to the two speakers from the NIH, whose presentations are summarized below:

  • How are biomarkers currently evaluated at the NIH?

  • How does the NIH interact with the FDA regarding biomarker evaluation?

  • Are there priority areas for research with respect to particular biomarkers?

  • How does the recommended biomarker evaluation process differ from current processes at the NIH?

PRESENTATION BY MICHAEL LAUER, NHLBI

Dr. Lauer began by drawing an analogy between the use of biomarkers and an event in the history of baseball described in the book, Moneyball: The Art of Winning an Unfair Game (Lewis, 2003). To assemble a successful baseball team, Billy Beane, the general manager of the Oakland A’s, was the first to apply rigorous analytic methods to identify which kinds of data best predict how much an individual player could contribute to a team’s overall success, rather than rely on conventional metrics. Dr. Lauer noted that this strategy resembles the notion “that by using the right statistics—the right biomarkers, so to speak—like on-base percentage and pitch count, one can come up with winning baseball teams without having to spend that much money.”

Turning to the report, Dr. Lauer noted that it identifies five types of biomarkers: physiological measurements, blood tests and other chemical analyses, genetic data, metabolic data, and measurements obtained from images. He provided illustrative examples—in the form of cautionary tales—representing each of these biomarker classes.

As an example of a physiological biomarker, Dr. Lauer described the exploration of ventricular premature beats, a form of cardiac arrhythmia. “In the 1980s, the presumed belief was that people who have lots of premature beats were at increased risk for [cardiac sudden] death, and if you got rid of the premature beats, you would save lives,” he said. This hypothesis was tested in the Cardiac Arrhythmia Suppression Trial (CAST) (1989). So strong was the belief that suppressing premature beats was life-saving that some considered this trial to be unethical, he said. However, the results clearly associated treatment to suppress ventricular premature beats with increased death rates.

Decades later, the NHLBI funded another trial examining the potential of an implantable defibrillator to reduce sudden cardiac death rates,



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