Big Data Poses Big Threat to FDA

image

There are hosts of ‘Big’ actors in the health industry that make the Big, Bad Wolf look like a saint: Big Pharma, Big Food, Big Oil, Big Corporations, Big Government, and Big Brother— the list itself is getting rather big.

But the public finally is discovering new means and opportunities to turn one ‘Big’ figure to its advantage: Big Data.

 

For too long, the FDA has had something of a monopoly on conducting the clinical testing needed for a given medicine or treatment to earn the government’s seal of approval. More importantly, they haven’t been terribly consistent or reliable in upholding their own standards, to the point that even drugs with FDA approval later turn out to be dangerous.

But the emergence of mobile applications and wearable technology have started to show potential for fundamentally changing this whole process, and break up the controversial relationship between the makers of pharmaceuticals, and the bureaucrats supposed to be responsible for keeping the public safe.

The more people volunteer to share their personal health data, especially when they are taking prescriptions or participating in new trials, the more, better information experts and consumers alike can potentially use to make more informed decisions.

This form of crowd-sourcing the information on drugs could break down the wall the FDA has long erected to shelter its approval and testing process, as well as increasing the accuracy and scale of testing.

 

Research universities are certainly no strangers to the merits of virtualizing the process: when unveiled its new Research Kit development product at SXSW in March, researches were thrilled at the efficiency it promised. An open sourced platform for app developers, Research Kit is intended to help build new, innovative programs for use with wearable tech (like the Apple watch, though not limited to it). Free technology like this can provide the means to organize and evaluate vast amounts of information—just like the FDA is supposed to do during clinical trials, but on a potentially larger scale than clinical trials allow.

Now that mobile devices are coming out with increasing capacity for individuals to accurately measure their own health data and record their medical experiences, they can choose to share the information not just in social media, but on sophisticated apps that don’t need major pharma companies or bureaucrats behind them to function.

Professors like Sharon Stoerger at Rutgers, have long endorsed and advocated the merits of digital mediums for education and academic development. With social media giving average citizens increasing leverage against agenda-ridden news and media companies, more and more people are turning online to find answers, even to questions of personal health.

 

One of the biggest obstacles to gaining more widespread understanding and acceptance of medicine that exists outside the government-managed mainstream, is that anecdotes from individual users—even if there are many of them—don’t fare well against the evidence offered by clinical trials. Giving average people the tools to track their experiences and bio-metric indicators, while they treat with natural remedies, levels the field with real data. This works the other way, too: patients taking conventional medication or other mainstream treatments can track their bodies’ responses and share precisely how FDA-approved drugs can be harmful.

Finally, we have a way to make Big Data fight for the regular people who want to know what works and what doesn’t in keeping them healthy—without relying on the FDA.

 

References:

 

http://fortune.com/2015/03/15/apples-researchkit-is-a-big-hit-at-sxsw/

http://www.americanpressinstitute.org/publications/reports/survey-research/how-americans-get-news/

http://pharmd.distancelearning.ufl.edu/news-and-articles/infographics/acetaminophen-still-the-safest-way-to-alleviate-pain/

Edgar Wilson