FDA: How Social Media Can Uncover Adverse Events

July 16, 2015
Lisa Henderson

Lisa Henderson is Editor-in-Chief of Applied Clinical Trials and Pharm Exec. She can be reached at lhenderson@mmhgroup.com.

Applied Clinical Trials

In light of two recent announcements, and this excellent article from Bloomberg it appears the role of social media in post-market adverse event reporting is being taken seriously by the FDA.

In light of two recent announcements, and this excellent article from Bloomberg it appears the role of social media in post-market adverse event reporting is being taken seriously by the FDA.

In June, at the DIA Annual Meeting, PatientsLikeMe and the FDA announced a research collaboration agreement to determine how patient-reported data can give new insights into drug safety.

PatientsLikeMe has a 350,000-plus active member/patient network online, who report on their real-world experiences in more than 2,500 conditions. The company’s drug safety initiatives began in 2008 with a pilot program that allowed patients living with Multiple Sclerosis (MS) to report adverse events directly to the FDA. One year later the company launched the first drug safety platform on social media, enabling industry partners to meet their regulatory obligations. In all, PatientsLikeMe has collected more than 110,000 adverse event reports on 1,000 different medications, data that the FDA will now be able to access and analyze as a supplement to traditional sources, including FAERS (FDA Adverse Event Reporting System).

The Bloomberg articles outlines a June 9 meeting that took place with Google representatives and the FDA to discuss Adverse Event Trending. The article further stated that the Google scientist in attendance was co-author for a report in which Yahoo search data was used to identify suspected drug reactions. The analysis was published in the peer-reviewed Journal of Medical Internet Research and demonstrated that search data can help find drug reactions "that have so far eluded discovery by the existing mechanisms,” which one could say includes FAERS.

FAERS is the cornerstone of the FDA’s post-approval drug safety surveillance, where reporting is mandatory for sponsors but voluntary for healthcare professionals and patients. This article from Applied Clinical Trials delves into the various reasons why hospitals and patients may not be reporting adverse events. However, adverse event reporting to the FDA has increased over the years, based on what many perceive is an easier online system.

Because PatientsLikeMe data are generated by patients themselves, as well as Google search or Twitter, it has the opportunity to increase patient input and can provide important real-time insights into drug tolerance, adherence and quality of life.

Speaking of Twitter, this recent news release found that Twitter hashtags can be used to discover drug interactions and unknown side effects. While it is not in the FDA wheelhouse as yet, it is being supported by the National Science Foundation, it has potential in uncovering drug interactions. Previous studies have shown that Twitter can be mined for drug issues, but using this new algorithm, a website was created that will allow an investigator to explore the connections between search terms (say "albuterol"), existing scientific studies indexed in PubMed-and Twitter hashtags associated with the terms and studies. A report on how the algorithm works, and its preliminary discoveries, was published online, June 8, in the Journal of Biomedical Informatics.

 

 

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