George Annas, JD, MPH

Do you think the services offered by 23andMe fall under the purview of the FDA?

If people wanted to know their genetic profile for recreational or ancestry purposes, the FDA would have no place in that discussion. But that’s not the case here. The company’s marketing materials stated that consumers could learn “hundreds of things about your health,” such as increased risk of heart disease, arthritis, gallstones, or hemochromatosis. This is a health claim, and once a company starts making health claims, the FDA has to step in. It’s true that the company was not legally obligated to turn to the FDA for approval, but now that it has done so, the FDA has the legal authority and obligation to act in a regulatory capacity.


Continue Reading

Does having this information directly from a lab pose a potential threat to consumers?

I think there is a significant threat. There is no validated way to tell the public what the test means for them. So the information could be misused, as the FDA made clear in its letter. The verbiage in the marketing materials advising people to talk to their physicians isn’t sufficient because many patients might not bother doing so and may take action on their own, based on their genetic profile. For example, if a person receives a report indicating that a particular gene can influence the dosage of warfarin, he or she might decide to change the dosage without proper medical input or guidance. So there’s information out there without a clear road map as to what to do with it.

Conclusion

Both experts agree that 23andMe is a “test case” for a host of broader issues, including the meaning of informed consent with genetic testing, privacy issues, and how this information will be used. In the words of Dr. Annas, “This is an opportunity for the industry and the FDA to come up with reasonable regulations for this relatively new field of direct-to-consumer genetic testing.”

From our Advisory Board:

“I am all about patient empowerment but information without proper education can be dangerous for and to the patient. In my opinion I would agree with the FDA, you really need greater amount of studies to show that the false positive and false negative rates are negligible. Patients that would use this information and not consult with their physician are really out there with possible misinformation. This can be used as an adjunct tool but not without looking at other risk factors. Family History, social history, occupational history and exposure all play a role in disease prevalence. It would not be providing a comprehensive picture to the patient regarding overall risk/benefit ratio.”—Carman Ciervo, DO

References

1. US Food and Drug Administration (FDA). Inspections, Compliance, Enforcement, and Criminal Investigations. 23andMe, Inc. 11/22/13. Document Number: GEN1300666. Available at: http://www.fda.gov/iceci/enforcementactions/warningletters/2013/ucm376296.htm. Accessed: March 16, 2014.

Do you think direct-to-consumer genetic testing kits pose a threat to patients?