The “Walgreens flap” mentioned below was the episode in 2010 when Walgreens announced that it would cell a genome testing saliva kit, but was pressured by government regulatory agencies, and withdrew the kit from the market within two days of the announcement.
(p. 119) . . . there will likely never be a “right time”—after we have passed some imaginary tipping point giving us critical, highly actionable, and perfectly accurate information—for it to be available to the public. The logical conclusion is that the tests should be made available. What’s more, the fact that they have been available has meant that democratization of DNA is real. Consumers now realize that they have the right to obtain data on their DNA. As a blogger wrote in response to the Walgreens flap, “To say that this information has to be routed through your doctor is a little like the Middle Ages, when only priests were allowed (or able) to read the Bible. Gutenberg came along with the printing press even though few people were able to read. This triggered a literacy/literature spiral that had incredible benefits for civilization, even if it reduced the power of the priestly class.”
The American Medical Association (AMA) sees things differently. In a pointed letter to the FDA in 2011, the AMA wrote: “We urge the Panel … that genetic testing, except under the most limited circumstances, should carried out under the personal supervision of a qualified health professional.” The FDA has indicated it is likely to accept the AMA recommendations, which will clearly limit consumer direct access to their DNA information. But this arrangement ultimately appears untenable, and eventually there will need to be full democratization of DNA for medicine to (p. 120) be transformed. Of course, health professionals can be consulted as needed, but it is the individual who should have the decision authority and capacity to drive the process.
The physician and entrepreneur Hugh Rienhoff, who has spent years attempting to decipher his daughter’s unexplained cardiovascular genetic defect and formed the online community MyDaughtersDNA.org, had this to say: “Doctors are not going to drive genetics into clinical practice. It’s going to be consumers …. The user interface, whether software or whatever will be embraced first by consumers, so it has to be pitched at that level, and that’s about the level doctors are at. Cardiologists do not know dog shit about genetics.”
Topol, Eric. The Creative Destruction of Medicine: How the Digital Revolution Will Create Better Health Care. New York: Basic Books, 2012.
(Note: first ellipsis added; other ellipses in original.)