FDA's Social Media Gambit 'A Long Shot,' Says Patient Advocate

The Food and Drug Administration wants to mine social media for information on adverse reactions to medications, but "listening to random chatter on the Internet," isn't the answer, says one patient advocate.

After more than a decade of ambivalence toward social media, the U.S. Food and Drug Administration is wading into the deeper waters of online communication platforms. In June, the FDA distributed a draft of long-awaited guidelines for industry when using social media.

Now the agency wants to employ listening technologies to improve the FDA Adverse Events Reporting System.

In late February, the agency quietly announced that it was looking for a contractor to take on the task of listening for adverse drug effects. It wanted to partner with an organization able to monitor social media sites, including Facebook, Twitter, LinkedIn, YouTube, Wikipedia for mentions of key words that would indicate negative side effects or other problems.

But depending on social media data mining for adverse event reports is a long shot, says Steven Nissen, MD, department chair of cardiovascular medicine and patient advocate with the Cleveland Clinic. He believes that monitoring consumer social media posts for adverse reactions will not bring the FDA any meaningful data.

"This is like listening to rumors," Nissen says, pointing out that a herd mentality often takes over online. "Someone tells you something, you tell someone else, it gets repeated as fact," he says, expressing concern that tweets about the negative side effects of a specific drug "bad" could cause widespread misinformation about it.

When the FDA submitted its 'sources sought' notice last February, it described social media as a new opportunity to interact with and educate the general public.

"The FDA is responsible for communicating about the risks and benefits inherent in all the products it regulates. The rise of social media on the Internet… has created new opportunities to interface with the public with respect to emerging hazard situations involving FDA-regulated products.

The increasing presence of social media promises new capabilities to monitor the effectiveness of FDA's ongoing risk communication efforts. FDA is in need of both historical and "real-time" monitoring and analyses of a representative sample of social media web sites."

One early indicators is not especially promising.

A 2013 study by social media monitoring firm Visible Technologies tracked mentions of 224 pharmaceutical brands across 257,000 posts during a 30-day period. In that time, it found that 0.3% of posts contained direct reference to an adverse event experience, and, on average during the reporting period, each pharmaceutical brand received a total of three posts that would meet the FDA's requirements for adverse event reporting.

The General Services Administration has been encouraging government agencies to begin employing social media monitoring and engagement with citizens via social media on a wide scale. Many private businesses have employed social media programs with great success, and some members of the government hope to see that success duplicated in the non-profit sphere.

The FDA, along with other government organizations, may be feeling the pressure to adopt cutting edge technologies.

Social media is trendy and no organization wants to get left out of it, says Nissen. "The FDA is [employing the social media monitoring strategy] just because it's very 'in' right now," he says. "I would never have recommended that the FDA use social media to monitor [adverse effects]."

Additionally, it would be virtually impossible for hospital leadership or medical professionals to participate in this program due to privacy regulations, says Nissen. "Doctors aren't going to be tweeting adverse effects, and the Twitter Generation doesn't take too many drugs yet."

While hospitals and health systems may have some success using social media monitoring technologies to keep up to date on patient concerns, the FDA likely will not find similar success, argues Nissen.

"I am not encouraged by this. Any information they get through these means will be very anecdotal and not very useful. If the FDA wants to get better data about adverse reactions, it will be through improving their current reporting systems, not by listening to random chatter on the Internet."