The Myth of Adverse Event Reporting

Article breaks down pharma's most common fears of social media and why the fears are unfounded. Could be good ammo for fearful clients.

http://www.doseofdigital.com/2009/01/myth-adverse-event-reporting/

Quoted from the article:

1. Afraid to give up control of the brand
Surprise, you already lost control of your brand. Conversations are going on without you already.

2. I can't track it like physician-level prescription data
Social media is no harder to track or correlate with sales than any other online program done in healthcare.

3. Older people use my products and they don't use social media
This simply isn't the case anymore. [...] In the US, there are over 4 million users over the age of 35 on Facebook, and that's just Facebook.

4. Adverse Event reporting
How often do posts include adverse events? Nielsen decided to take a look at this rather than simply assume it was "a lot". Nielsen looked at Yahoo Health boards and took 500 postings. Of these, only 1 contained enough information to qualify as an adverse event that needed to be reported. That's 0.2%.

Suppose for a moment there were several adverse events that need to be reported. How often do they need to be reported? The FDA is pretty clear on this. For new drugs, reports need to be filed quarterly for three years. After that, it's annually. For "serious and unexpected" events, these have to be reported within 15 days. However, there's a pretty high threshold for an adverse event to be considered "serious and unexpected."