How Many Adverse Events Are On The Internet?

How Many Adverse Events Are On The Internet?

November 11th, 2011 // 1:47 pm @

There is no debate that the Internet holds many potential riches for drugmakers seeking insights into patients. Consumers always have something to say about effectiveness and marketing. Yet many pharma folks dread combing through blogs, Facebook, forums and Twitter feeds, among other things, because they live in fear of having to file adverse event reports with the FDA.

But are those fears really justified? Maybe not, at least according to a new analysis by Visible Technologies, a social media monitoring and software firm, which examined more than 257,000 posts about 224 different products – 33 antacid over-the-counter meds, 38 over-the-counter decongestants, 10 prescription statins and 143 prescription drugs used to treat high blood pressure.

The upshot? Only 0.3 percent of the posts mentioned an adverse event, and 14 percent of the posts that contained an adverse event had an identifiable name and a way to contact the post that would make it possible for a drugmaker to fill out required paperwork. The analysis was conducted over a recent 30-day period.

What kind of sites were scoured? Posts were collected from millions of sources, including blogs; reader forums; message boards; message groups; social networks, notably Facebook and LinkedIn; Twitter; regular news sites; specialized health sites, such a WebMD; and video and photo sites, such as YouTube and Flickr.

And the purpose in choosing the types of meds that were reviewed was to cast as wide a net as possible, given that so many people use over-the-counter antacids and decongestants, as well as get prescriptions for treating high cholesterol and high blood pressure.

The analysis was extended to a subset of 12,530 posts that were deemed likely to contain an adverse event, based on the use of certain terminology. Among these, just 3.3 percent mentioned an adverse event – the rate was nearly identical for both OTC and prescriptions meds – and only one in seven posts with an adverse event report contained info to meet FDA reporting criteria. And 56 percent of adverse event posts had contact info that could be pursued, such as private messaging on a forum.

“There’s a big hesitation among pharmaceutical companies to go on the Internet, even though there’s so much valuable information there that every other industry is reading,” Jackie Kmetz, Visible’s director of community educational outreach, tells us. “But pharma is under a heavy cloud because people worry there may be a heavy load of (adverse event) reports to file.

“But when you look at the huge volume of comments, it’s actually not an overwhelming or intimidating amount of reporting they’re going to have to do. It’s actually very low risk. What this (finding) does is take the pressure off them, that fear of the unknown, of what’s out there and what they’ll have to do in response. It’s a ridiculously low number. The amount of follow up would be tiny.”

Of course, some brands are going to generate more adverse event reports than others, and it can still take time to sift through an analysis and do any required paperwork. Like it or not, though, drugmakers are going to eventually begin this exercise. To what extent and how fast this will occur, however, seems to largely depend on when the FDA gets around to issuing social media guidelines.

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