The Real AER Numbers - Hidden in the Data

Last week, a USA Today article commented ‘loudly’ on the adverse events associated with dietary supplements in the first part of 2008, noting that some 600 instances were reported, including 5 deaths. Predictably, industry detractors have used the data as part of their personal vendettas against the industry, while supporters have quickly pointed out that this number is far less than that associated with OTC products (let alone Rx drugs), and that the author of the article himself ( indicated that an FDA spokesperson reported that “"Some of these deaths were likely due to underlying medical conditions.”

The article title was obviously intended to generate headlines – Dietary supplements cause 600 ‘adverse events’. They did so. The lack of more specific details led the reader to believe that this was an unexpectedly high number, and directly attributable to supplements alone rather than drugs or other causes and conditions. We should not be surprised, as an industry, at the messaging supporting the release of this information, but it is incumbent on us, once again as an industry, to put the data into context and to contribute to what the record will ultimately show for this set of numbers.

The data themselves, according to the article, included 368 mandatory reports from supplement manufacturers and 236 reports from consumers or health care professionals. The availability of the information itself is partially attributable to the AER legislation passed in 2007, which industry strongly supported. Numbers floating around at that time suggested we’d see anywhere from thousands per month (if you believe detractors) or a few scattered, mostly with challenges in proving causality (which we are apparently seeing). So one can argue that we were right and we were right (the legislation was positive and the number was low) rather than certain senators currently accusing industry of fundamentally believing that the number of AERs was zero, hence now arguing that supplements are unsafe. When placed in context of recent food safety issues, the reported number of AERs pales even further and theoretically, should silence all but the most staunch of opponents.

Such is not the case though, because memory is fleeting, context and misuse of data is everything, and when it counts, industry’s voice seems unable to head off the Durbin’s and others of this world.

There are many ways to interpret numbers and data. For better or for worse, politicians and the media are the masters in this field.

Hide comments


  • Allowed HTML tags: <em> <strong> <blockquote> <br> <p>

Plain text

  • No HTML tags allowed.
  • Web page addresses and e-mail addresses turn into links automatically.
  • Lines and paragraphs break automatically.