Tuesday, December 6, 2011

Dii POV: AdverseEvents.com launches; questions FDA validity

A fairly new website, AdverseEvents.com, started by a few guys from Sapient Research, seeks to provide a better user experience and more accessible data on side effects and drugs for consumers and healthcare professionals. RTC has written a full POV which you can read online.

The site is controversial for two reasons. One, it has been publishing reports which suggest that the FDA is not accurately assessing side effects incidence rates. Two, it is gathering its data on side effects from 3 sources, 2 of which are unvetted and unregulated. AdverseEvents.com gets their data from the FDA's database, online user submissions and social media commentary. They aggregate and publish this data on their website which is free to the public (a more robust version is available for a subscription fee).

The site has only been in market since September, and it has yet to make a dent in daily traffic or search results, but it has gotten people talking about the implications of an outside entrant publishing information on side effects and evaluating risk.

Download the PDF from SlideShare: http://www.slideshare.net/rtc123/rtcrm-povs-adverseeventscom-november-2011


  1. Sara:

    Thank you for posting this and making your full report available. I think your report is largely accurate, but want to correct a couple of key facts.

    The main one is that we use data that we get from the FDA, direct patient report, and from social media interchangeably. Currently on our site we have over 3 million side effect reports that we've cleaned up and aggregated from the FDA's AERS data. That information is the sole source of data we use for our published studies (including the one you referenced on epilepsy drugs) and the vast, vast majority of data we present on our website.

    As you note, we do allow users to report their own side effect experiences on our site and we are actively monitoring social media and other internet outlets for adverse event information. However, none of the data we’ve collected from social media is made available on our site currently (specifically for the reasons you cite). Moreover, all data we collect from direct reporting is filtered out in our studies and our users are able to filter out those data using our querying and alerting tools.

    But, more importantly, I think that what your report is missing is why we're looking to sources other than the FDA for data. The reason is that the FDA estimates that they collect information on at most 10% of adverse events annually. The chronic under-reporting is due to a number of factors, such as the difficult reporting process and the lack of reporting requirements on anyone other than drug manufacturers. The bottom line is that the FDA data is woefully incomplete. And, what little data that is available is released on a time delayed basis and presented for use in a format that is virtually unusable - an unstructured ASCII format with no standardization or aggregation of terms or names.

    We agree with your assessment that that our success hinges on acceptance of our data and methodologies. But we also believe that our success hinges on our ability to deliver a more complete, transparent, and accurate view of drug safety than what currently exists. To that end, we are very open about our processes and make most of our work available online for all to see, question, and query. And we have already found that many in the healthcare community – pharmaceutical companies, providers, and others at the point of care – are actively using and engaging with our data.

    Also, my background is from Sagient Research, not Sapient.

    I invite your questions or comments.

    Brian Overstreet

  2. Brian- Thank you for your comments and corrections! We will update our document accordingly.

    We were unclear on what was currently being done with the social media commentary and are pleased to hear that you are filtering out that information. We too, use social media conversations to derive directional insights—social media is a fantastic quick-hit qualitative tool—but we’re happy to see that it’s not currently part of the quant portion of your analysis. It will be interesting to see what methodology, if any, can be built to assess online comments and if social networking continues to become more descriptive, especially in the health space.

    As a consumer focused agency, with many pharma clients, we’re all about transparency and credibility; we applaud that AE.com is making this important information more accessible to the public (and to our clients). We are understandably, of course, curious about what implications this will bring to such a highly regulated market, and have to approach such things with a cautious tone. It sounds like AE.com has an admirable approach to health care, and we we look forward to learning more.

    And Sagient, of course! Apologies!

    Thanks again for your insights and comments.