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What the FDA decision reveals about medicine today

A couple of weeks ago, the Food and Drug Administration (FDA) approved a new genetic risk panel from 23andMe, a direct-to-consumer genetic testing company. This news is significant in the world of medicine and evokes several questions, including:

1)     Are we prepared for patient-driven medicine?

Medicine has historically taken a paternalistic attitude toward testing, based on the idea that clinicians are better able to determine the right tests and interpret results. Now here we are, enabling people to order their own commercially available tests, which could have huge implications diagnostically, financially and ethically. For example, the 23andMe panel screens for risk of Alzheimer’s Disease and Parkinson’s Disease – are patients, clinicians and payers equipped to respond if results are positive?

2)     Where’s the scientific rigor?

The FDA has approved this new panel, focusing on genetic risk factors for a few diseases, but there is a lack of academic scientific scrutiny around it. Why were these tests chosen and not others? What outcomes or epidemiological studies were the basis for these decisions? I’ve not seen any stamp of approval from academia, which makes me cautious.

3)     What’s next?

This decision is more evidence that consumers have a growing appetite for genomic medicine. I’ve noticed in my own patient base a significant mood shift over the last several years. Patients are more interested in knowing their health risks than ever before. FDA approval of this panel is the first step in what will likely become patient access to ordering their own exome and full genome testing. It puts a spotlight on the murkiness of what happens next, once the results are in.

Proceed with caution: The benefits and risks of patient-driven medicine

Please don’t get me wrong; I am greatly in favor of patient empowerment, and I believe that consumer-driven health care will ultimately be good for all. However, we need to balance patient and consumer demand with evidence and science-based policy.

This tension can be exemplified by last year’s revision of mammography guidelines by the American Cancer Society, partly based on high false positive rates in younger women. Many patients ignored this science and demanded annual tests. The public applied pressure to payors to continue older recommendations.

With the mammography example and direct-to-consumer genetic testing, we see a trend emerging: Patients will be increasingly frustrated as they wait for conflicting policies to set their course in health care. Even though medicine hasn’t fully addressed aspects of genetic and genomic medicine – the legalities of insurability, for example – the market is moving ahead to meet consumer demand.

What people want is often different from what academia recommends. For health care to be successful in improving outcomes for patients, we’ll have to strike a careful balance between the old way of doing things, and the new.

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