In Elizabeth Murphy’s article, “Inside 23andME Founder Anee Wojciciki’s $99 DNA revolution“, she raises a number of important issues about the implications of the DNA technology that 23andME is now leveraging and sharing with its customers.
What 23andMe has shown is that society is looking to game changing technologies focused more on prevention than just treatment.
If you look at the data and the community that 23andMe has established for Parkinson’s you can see clearly why and how much this could matter, both for this company and as a general concept that will grow and mature.
It seems clear that at some point healthcare companies will be able to leverage the DNA data to develop approaches and medicines for prevention. This is both a threat and an opportunity for medical industry organizations. Those with enough vision will likely push healthcare forward, with or without reaping financial rewards. The aggregated data also may be leveraged to expand community reach and customer insights, so vital to good segmentation, communications and more. Despite the many challenges that this field will face, including push back from the medical community, the bottom line is that this field is moving forward and is feeding people’s desires to live longer and healthier lives.
In fact, even the early challenges of gaining acceptance are now overpowered by the heart-stopping decision by the US FDA last month.
According to a major news report three days ago, genetic testing company 23andMe Inc. will comply with a Food and Drug Administration directive from last month to stop providing access to health-related reports from its tests during a regulatory review. However, 23andMe will continue to provide ancestry-related information to customers and raw genetic data without interpretation. Those customers could receive additional, health-related information in the future, depending on whether the FDA grants marketing authorization. Customers who bought kits since the FDA order came out late last month also will be eligible for refunds. (http://www.nbcnews.com)
23andMe claimed that its test kit, launched more than five years ago, could tell customers about their risk for more than 250 diseases and health conditions. The company sells its tests online. Customers receive a small tube in the mail, which they return to the company with a saliva sample for DNA analysis.
Here is the problem: After 5 years of allowing (or rather, watching and wondering…), the FDA says only medical tests that have been cleared by the government are permitted to make such claims. As a result, last month, the agency ordered 23andMe to stop marketing its test, warning that erroneous results could cause customers to seek unnecessary or ineffective medical care. The FDA warning letter stated that even after numerous meetings and email exchanges with the company, the agency still had no assurance that the firm has analytically or clinically validated its technology.
This article reminds us of Eric Topol’s key theme in The Coming Revolution – where he foretells of the pushback from doctors and governments who, quite simply, don’t know how to embrace and integrate companies and technologies such as those of 23andMe into a new healthcare paradigm. The Fast Company article cites several examples faced by the author’s own providers – from her older primary care physician to her genetics counselor. However, she also points out how helpful the tests have been, not only to help ascertain certain health risks, but in connecting her daughter to cousins she did not know about, facilitated by a special Facebook set up for them.
In this new world, this article illustrates how healthcare decision making is being driven by an increasingly informed consumer and by companies such as 23andMe who have dared to driven this paradigm shift. Sadly, however, the shift now is not likely to happen quickly, as the FDA is not known for rapid decision making unless there is huge public pressure. Its favorite death-knell phrase that buys them time is, “We want more data.” And other agencies around the world including the S Korean FDA now will likely take a “You see! Let’s wait and see what the FDA says.”
Who do I think will win? Short term, the FDA, but longer term, my bet’s on 23andMe (and me!).
INSIDE 23ANDME FOUNDER ANNE WOJCICKI’S $99 DNA REVOLUTION, by Elizabeth Murphy, Fast Company, Nov 2013
