Adverse events database not useful for drawing safety conclusions, expert says
Adverse event reports have been part of the dietary supplement industry since 2007. But what’s new this year is the Food and Drug Administration’s decision to make the data within these files public, something that was done in late 2016. Rick Kingston, PharmD, a professor of clinical pharmacy with the University of Minnesota. said that the way that has been done gives the impression there is useful information to be gleaned from these files, which in their raw form is simply not the case.
Kingston said that the way their adverse events are entered into the data base conforms to the letter of the law. But it does not represent a very useable data set. Too much information is missing, and much of what is there is too imprecise. For example, a consumer might complain that they had chest pain after taking a particular supplement, but decline to be more specific about what kind of pain they experienced. Was it a true cardiac event? Heart burn? Something else? They might also indicate that they were treated for the complaint but decline to provide information about what kind of treatment or about what the attending physician had to say about the situation. This particular example might entered using standard medical codes as a case of angina, a potentially serious complaint.
Noise clouds signal
“When you look at the events that come in it’s really only about 5% or maybe 6% that signal something that needs to be looked at,” Kingston said. Kingston, who is President, Regulatory and Scientific Affairs at SafetyCall International, spoke with NutraIngredients-USA at the 17th Annual Oxford Conference on the Science of Botanicals put on by National Center for Natural Products Research at the University of Mississippi. The conference wrapped up on April 6.
Despite the shortcomings of the system, Kingston said it is still a very valuable tool for responsible companies when treated with the proper filters, so to speak.
“The best practice companies actually do analyze their adverse events experience to get a good handle on those types of events that they really need to take a closer look at and the events that are more likely representative of the background noise that you get in all spontaneously reported adverse event management,”he said.
Kingston said FDA released some but not all of the data associated with each adverse event report in an attempt to be more transparent to the public. But without the narrative associated with the event (information that FDA chose not to release), Kingston said it’s hard to get a handle on exactly what role the supplement or ingredient played in the event.
“I don’t think anybody can look at that data set and draw any conclusions. It’s just not amenable to that type of analysis,” Kingston said.
For more information on what was on the agenda in Oxford, click here.