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The FDA's Adverse Events Report database holds 77,000 reports.

FDA's adverse event reports: Transparent but not relevant

The FDA opens its Adverse Event Report data with little context and no causality.

An industry dedicated to transparency may be feeling a bit like somebody opened a window that only lets in negative light this week as the FDA opened the Adverse Event Reporting files to the public, with hundreds of cases presented without context and with scant detail.

A 16 megabyte spreadsheet with nearly 77,000 reports across the last dozen years, downloadable off a link on the FDA web announcement, offers everything from an upset stomach linked to bag of lettuce to the 47-year-old who attributed his prostate cancer to a multivitamin. That’s about all the detail you get at the spreadsheet level—case number, date, “suspect” product, age, sex, vague severity and symptoms. It’s a curiously entertaining skim, but a skim is all it is.

In the Dec. 6 announcement, the FDA is clear that the adverse event report does not mean an adverse event actually occurred as reported, or that it was tied to the suspect product. But it doesn’t say it’s not, either. It’s hard to believe a Flintstones chewable vitamin would cause a premature birth, but the question becomes whether Fred Flintstone is guilty until proven innocent.

Industry veteran Scott Steinford is an obvious fan of transparency in his role at Trust Transparency Consulting, but he was quick to question the worth of the FDA data dump. “While the concept of transparency by FDA is to be applauded, the usefulness of the information remains lacking,” Steinford commented by email, pointing to a case in May concerning a man who was taking 16 different supplements when he suffered heart failure. Without details, it’s guilt by association, at best, he adds. “It could be presumed other health issues might have been present, but it is impossible to know from this information.”

The Council for Responsible Nutrition issued a statement supporting the FDA’s action, noting the industry had lobbied for the AER system, but the council also questioned the value and suggested consumers were better off following the agency’s consumer advisories than “looking at individual adverse event reports which, at the end of the day, may not be related to the supplement product.”

In its statement, the Natural Products Association charged that the data could leave the industry unfairly exposed to lawsuits. NPA Executive Director and CEO Dan Fabricant stated: “We will be monitoring closely how this information is interpreted and used and will speak out if the system is abused at the cost of small businesses. We have to be certain this is a tool for consumers, and not for the Plaintiff's bar to file frivolous and irresponsible lawsuits, given that the vast majority of these AERs are not causal.”

NPA executive board member Mark LeDoux also questioned whether people might “jump to conclusions of causality without all the facts.” But LeDoux, CEO at Natural Alternative International, also noted that, properly interpreted and examined, AERs help legitimize the industry. “In the larger context, the numbers of serious adverse events of dietary supplements, and not counterfeits which have undisclosed active pharmaceutical agents, should demonstrate widespread safety when compared to over-the-counter medications.”

Explaining the intricacies of AER reporting will be a challenge, but could prove an opportunity for the industry, according to Megafood CEO Robert Craven. But Craven, an outspoken advocate for transparency, says the AER files are part of a necessary movement toward complete openness. “The pros of AER transparency outweigh the cons,” Craven wrote in email.  “Transparency builds trust with consumers. Period.” The challenge of explaining AERS to consumers is another opportunity for “dialogue,” Craven wrote.

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