Has the FDA dealt a lethal blow to 23andMe?

I'm based in Europe, and so it was the afternoon today, when the news of the FDA warning letter to 23andMe surfaced. The FDA have asked the company to stop selling the 23andMe Saliva Collection Kit and Personal Genome Service (PGS), which is basically the only product of the company.

One year ago, I had the great fortune to be the panel moderator at Medicine X, (Stanford Medicine, Palo Alto). Medicine X is a partner conference to Doctors 2.0 & You. Anne Wojcicki the brilliant  and charismatic co-founder of 23andMe described her company's genetic testing service and why she had created it. Here's the video.  

Two reasons for consumers to use 23andMe, according to their CEO: consumers own their data and once they know their results, they can take preventive actions. Everyone must act instead of remaining unknowingly at risk for the inefficacy or intolerance of certain drugs, or at risk for certain diseases. 23andme had tested Sergei Brin, the Google co-founder and then spouse of the 23andMe cofounder and found that he had a high risk for Parkinson's disease.

What can a patient do with the information? This is a different story, and that is where the PGS becomes a device, in FDA terms, a device that is not authorized to be one. Yet, in listening to the video, it sounds like 23andMe makes action recommendations based on  the test results.

When I asked the Silicon Valley audience for a show of hands on how many people had done a genetic test, almost everyone's hand was raised. And genetic testing isn't limited to 23andMe. They have competitors (who must be quite concerned as well).

23andme had dropped its price this year to go to mass market. At $99 a test, 400 000 users had signed up. This growth may well have contributed to the FDA's timing...They couldn't wait any longer with that number of users.

The FDA warning letter is here. It's not news to 23andMe, because the FDA had begun to raise red flags in 2009, two years after the company's launch. The FDA said, "you are a device. Please act like one." Who knows why they didn't heed the warning? Was it impossible to maintain a going business and undertake the investment? Was it lack of experience with the regulatory side of healthcare? Was it some form of internal miscommunication?

I believe that if 23andMe had been managed with strong input from managers with drug and device backgrounds, the business would have taken the FDA requests very seriously and not moved forward in the same way.. I would imagine that there would have been investors to follow them on that solid if slower path.

The story will surely unfold over the coming weeks...

 

 

 

 

 

 

 

 

 

 

 

Quantified Self, Connected Objects, Crowdfunding, Kickstarter, Intelligent Fork #doctors20 #eatingslowly

 

"Digital" gets lots of attention for sure. But one underplayed impact of digital is the new vocabulary it generates. Quantified Self refers to self-measurement by individuals interested in understanding the data our body produces. Quantified Self goes along well with connected objects. The connection between the objects is digital of course; the objects are connected to the web to transport the data. An example is the intelligent fork, invented by Jacques Lepine of SlowControl.com -- the fork that knows when we eat too fast (HAPIfork)

Next along comes crowdfunding, a second generation method for getting financed, thanks to the wisdom of the masses. It's also CGU but the "c" is for contribution generated by the user ;-), if I may. Since many of these connected objects come from start-ups, some financing model has to be found. Kickstarter is a leader in the area of crowdfunding, and so it was normal that the intelligent fork would benefit from this great platform for a campaign running through May 31.

And then one week later, the intelligent fork will be present at Doctors 2.0 & You, June 6-7 in Paris, which is one of the reasons why I'm posting this information. Jacques Lepine and Fabrice Boutain travel the world, but they'll be together in Paris. So, if you can't see them in the US or Asia, try to make it to Paris, the world's conference center. We'll be waiting there for you. And that's not virtual.

 

 

 

Healthcare Social Media: What Can We Learn from a Fork? Or 8 Reasons for Slow Control to Succeed.

In the first few days of the New Year, we are always smothered in summaries, insights, and perspectives on the year past and the trends to come, especially in the fast-moving area of digital communication.  What and who will succeed on the web, in Social Media, in Mobile Apps? What's going up? What's coming down? You get the picture. But, to my mind, there is only one question? When will healthcare "get it" in a major and concrete way?  When will digital healthcare play as much of a role in as many people's lives as say e-commerce ? The answer is Marketing 101: when what people want, the products, and the business models are aligned. We aren't there yet.

Where I'm going with this, is that some innovations do speed forward with less effort than others. And herein lies my story about the potential success of Slow Control, a company -- which in all transparency has been a client since 2012. Their first product, a digital fork branded as the HapiFork, has been unveiled at the Las Vegas Consumer Show. This fork vibrates when the user eats faster than he's supposed to and it generates graphs of the user's eating speed. Why set up such a system? Because eating too fast is unhealthy and conversely "eating slowly" has various health benefits on digestion, metabolism, weight management.

We are seeing an extraordinary amount of interest in this internet-connected fork, the concept of "eating slowly for better health" which it supports, and the story of the inventor, Jacques Lépine. Journalists and bloggers are very present. The exhibit stand is never empty.

And so, we ask ourselves "why this one"? What are the lessons learned? Here is my take. My theory is that Slow Control is capturing everyone's imagination for a number of reasons.

1. A fork used for eating is an important and ancient tool going back to the Egyptians and Romans. 
2. It is something that everyone  likes, because it means that serious food is not far away. 
3. A fork is a three-dimensional object that everyone can easily visualize.
4. Eating is one of the most positive human activities that people can discuss and food, unending in our interest.
5. Eating too fast is something that almost everyone thinks they're guilty of at least occasionally.
6. The concept of the fork has not had a major technological innovation, since perhaps the introduction of plastic, and none as significant as the integration of electronics.
7. The application of the quantified self approach to the fork is a mindbender. Everyone knows that we can count and graph our steps, calories consumed, weight gained, heart rate, and blood pressure. But no one even knows how many forkfuls we take a day, let alone how to record them.
8. A new entrant (Slow Control) to the market has brought all of this together in one product and the interest skyrockets...

Generating buzz is  "not simple" as all that. Look at how many valid public health campaigns have failed to interested the consumer. But, develop a way to measure for the first time an important human activity, and as such transform a historic object...and you're bound to stir things up...It's not about trends in general. It's about what makes us tick...Hey, we can count that too.