Instead, drug companies are just ignoring potentially vital adverse event reports.
Image: Rennett Stowe
Pharmaceutical companies are finding that the best—or at least safest—route to take with social media is to just ignore it. Given the a so-far unadapted FDA regulatory scheme for communication via things like Twitter and YouTube comments, rules for how drug companies can and can't interact with consumers online have remained prohibitively vague.
If a patient posts something online, like "this drug made my face turn into a giant boil," does it count as the sort of adverse event that pharmaceutical companies are required to report to the FDA? Historically, an adverse event is an adverse event, but the word-barf of social media makes this a murky proposition. If that's an adverse event, then what are the responsibilities of the drug manufacturer in tracking those events, which might pop up in any number of places online, from obscure message-boards to an @-tweet to, indeed, a YouTube comment?
It's nice to imagine a system, likely administered by the FDA, for mining comments like that, but in the meantime this is yet another online Wild West. Believe it or not, drug companies are in fact capable of playing it safe, especially when it comes to regulation, and so just about 50 percent of all pharmaceutical companies are choosing to sit social media out. This is according to a report published in Nature Biotechnology outlining a state of confusion that's hampering Big Pharma's marketing efforts, sure, but also repressing information that could prove to be critical in assessing the ongoing safety and efficacy of drugs, from clinical trials to the marketplace.
There are two broad categories of problems. One has to do with trials, which can drag out for extended periods of time in which supposedly blind trial subjects are free to post and read whatever they want online. And they do. In 2014, a trial for a drug designed to treat amyotrophic lateral sclerosis was effectively nuked as subjects described their symptoms on the forums of PatientsLikeMe, revealing who had and who hadn't received the experimental drug. The study was then no longer blind, with 27 percent of trial participants active on the same site.
Health is a hyperactive topic within social media
The second category is what's known as "pharmacovigilance," a guiding force in pharmaceutical research and manufacturing since the 1961 thalidomide disaster. It is what it sounds like: Essentially, it's the science of adverse reactions. Some of this information is provided to drug companies through pharmacovigilance agreements with doctors and patients or "spontaneous" reports, while some comes from research, the media, and regulators themselves. Theoretically, adverse event reporting comes from anywhere, and in most countries, drug companies are required to submit this information to regulators.
It's a data quandary then. Health is a hyperactive topic within social media, as anyone that's spent much time on illness-related forums can attest, and so it should be a golden age of adverse event reporting. But how to actually do that and when to stop is an ugly science. How are social media comments to be weighed? What sources count as quality data? What's to keep an anti-vaccine brigade from trying to sink a safe, life saving drug?
"With social media, anybody can publicly complain in just 140 characters," the Nature report frets. "It's not yet clear under what circumstances companies are supposed to be monitoring these reports, so many of them are choosing the simplest option: ignore."
But ignorance really shouldn't be an option when it comes to adverse event monitoring, particularly if it's intentional ignorance. So what now? The FDA will be coming out with updated guidelines at some point TBD—it published some "vague and overbearing" preliminary guidance in 2014—but the issue really shouldn't be of what on social media drug companies are allowed to ignore so much as what the FDA can do to net as many possible social media comments about potentially dangerous pharmaceuticals. It could be a golden age, or it could be Big Pharma business as usual.