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# Researchers Question Precision Medicine Value
- URL: https://www.fdaweb.com/researchers-question-precision-medicine-value/
- Published: 2016-01-06T12:00:00.000Z
- Updated: 2026-09-15T02:25:42.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5134353

> While in a few cases genetic information has proved useful in screening and treating diseases, in general the broad application of genetic information has not yet been shown to be helpful, despite considerable hype suggesting imminent and overwhelming benefits. That’s the conclusion reached in a *CardioBrief* [analysis](http://cardiobrief.org/2016/01/05/jama-study-precision-medicine-flunks-test-gets-left-back-in-second-grade/?ref=fdaweb.com) of a research article and accompanying editorial published in the *Journal of the American Medical Association* (links to abstracts in the *CardioBrief* report).  
>  
> The analysis says the *JAMA* study “gives strong evidence that broad scale general use of genetic information will have very little value in guiding health decisions, and even has the potential to cause far more harm than good. In particular, the study shows that incidental findings from genetic screening strategies have a very long way to go before living up to the hype of precision medicine advocates.”  
>  
> The study looked for variations in two genes that have been shown to play a major role in two well-known potentially lethal cardiac rhythm disorders. Researchers sent the genetic sequences of 2,022 people without previously known arrhythmias to three separate laboratories for analysis and then looked at the patients’ electronic medical records, which often included electrocardiogram tracings.  
>  
> While the labs found that 11% of the subjects had rare gene variations, and 63 subjects had variants that have been linked to disease, the patients with the variants were no more likely than those without them to have any evidence in their medical records or ECGs of heart rhythm problems. “We found a high frequency of potentially pathogenic mutations without a high burden of disease,” the study authors wrote.  
>  
> The accompanying editorial says the study “calls into question how existing knowledge of genetic variants translates to predicting outcomes in unselected and ostensibly healthy individuals.”  
>  
> An equally disturbing study finding, *CardioBrief* says, was the “enormous amount of discordance between the three laboratories in the studies. In fact, there was very little overlap between the three labs, with each lab reporting genetic variants distinct from the other labs.” The researchers called for serious work by laboratories to standardize variant interpretation.