Can web searches help the FDA monitor drug safety?
Momentum is building behind the idea of using internet search engines to feed information to the US FDA on adverse events linked to drugs and medical devices.
According to a Bloomberg report, the FDA held a conference call last month with Google to explore the concept and had also been in discussion with Microsoft about a similar approach using its Bing search engine.
The FDA wants to explore whether by ‘data mining’ search engine queries can be used to provide an early warning of an emerging toxicity problem. A similar idea is being explored in a European initiative looking at smartphones, apps and social media.
At the moment, the agency tracks side effects through a combination of voluntary and mandatory reporting channels which all feed into its FDA Adverse Event Reporting System (FAERS). In a nutshell, use of the system is a requirement for biopharma manufacturers and optional for doctors and patients.
The FDA staffer on the call – Evgeniy Gabrilovich – is one of a pair of authors alongside Elad Yom-Tov who published a research paper in 2013 in the Journal of Medical Internet Research which described a continuous monitoring approach to post-marketing drug surveillance based on the Yahoo search engine.
“Existing mechanisms for post-market drug surveillance work well in many cases, but failures resulting in harm to patients and even fatalities are widely documented,” they report in the paper, which concluded that adverse event reports (AERs) found in this way could be tested in phase IV clinical trials.
Two other FDA researchers – Sirarat Sarntivijai (now at EMBL-EBI) and Darrell Abernethy – reported in a comment submitted to the journal Clinical Pharmacology & Therapeutics last year how web searches could provide invaluable intelligence about side effects, although they noted that the methodology that should be used “is not well characterised, and the utility of such analyses is not well defined.”
The FDA has already started to embrace technologies to help it cast the net wider for adverse event monitoring – for example its MedWatcher mobile app lets anyone with a smartphone or tablet to report side effects with medical devices and also upload images that can be used to identify visible problems such as breakage or corrosion.
Use of a data mining approach would however mark a significant departure from its current approach and is a renaissance – and extension – of a plan first proposed by the agency in 2013 but dropped later that year because of a lack of funding.
Last year, the agency resurrected the idea of mining peer-review literature reports for AERs but once again shelved the plan, saying it would be re-advertised at a later date.
The agency is not commenting on its search engine plans at the moment, reports Bloomberg, and described the conference call as a “preliminary introduction” to the concept.
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