The FDA is interested in learning more about how pharmaceutical companies track adverse events on the Internet and have asked the public to submit comments in preparation of the November hearing on the Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools (see here and here).
Specifically, FDA needs answers to these questions about social media/Internet and AE reporting:
- How are entities with postmarketing reporting responsibilities and other stakeholders using the Internet and social media tools with regard to monitoring adverse event information about their products?
- How is adverse event information from these sources being received, reviewed, and processed?
- What challenges are presented in handling adverse event information from these sources?
- What uncertainties are there regarding what should be reported from these sources to meet FDA adverse event reporting obligations?
Here's the post:
Since it's been discussed here....pharm. co's...First, this may be part of the answer to FDA's first question about AER (Adverse Event Reporting). J&J seems to take it very seriously, although we cannot be sure this is true -- I cannot verify who the poster is or contact him/her to get verification. This illustrates the main problem with tracking AEs online: you often cannot identify the person making the report or the patient who suffered the AE (see FDA's question #4, above).
For those that don't believe in "Big Pharma"
I am a member of BzzAgent, an online networking site that offers free trials or products to people as a means of marketing. They basically send you info and either coupons or free samples (or both) to help you convince other people to use the product in question (i.e. I did one for dog food and one for an OTC anti-histamine). Kind of like grassroots marketing. You only get offers targeted for your demographic group, of course.
I just took a survey through BzzAgent for Johnson & Johnson, which basically was more of a "contract" where if chosen, I agreed to notify J&J if I became aware of any negative talk about their products. It was all couched in terminology implying that I would only be doing this as a representative of J&J, and only because it was "required by law" for all J&J employees to report any and all "adverse events" associated with use of J&J products. It mentioned that I would be under obligation to report anything I heard, even if on the internet, including contact information for the person stating the problem. Nothing about getting their permission to relay that information, which stuck out given the detailed, "legal" approach of the survey.
So, basically - agreeing to be a "troll"
POSTED BY: "Chris Braile" [Profile not available on site]
According to my survey on this (see here), 94% of respondents agree that "Usually, there is uncertainty regarding the true identity of the reporter" and 88% agree that "Usually, there is uncertainty regarding the true identity of the patient."
"Chris Braile" points out another problem: relaying personal information gathered on the Internet to a pharmaco by consumer agents may violate (or seem to violate) the privacy of the reporter. Chris seems to think it is sleazy to require him/her to do this (assuming there is any personal information to report).
It is not known whether the J&J contract with Chris says that reports should be made ONLY if there is knowledge of the four basic elements for submission of an individual case safety report (ie, identity of the reporter, identity of the patient, identity of the drug, and certainty of seriousness of the event). Yo9u cannot expect a consumer hired by BzzAgent to know if all the requirements are met. Therefore, J&J is asking these consumers to scoop up and report everything, which makes it necessary for J&J to sift through these "trolled" reports to find any that meet the requirements for reporting to the FDA. No wonder many pharmacos find this too daunting a task and give up on getting involved in social media. J&J may be an exception, also UCB (see "Finally, a Drug Company Embraces Social Media, AEs Included!").