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Advera Health Analytics, Inc.

Failure to Warn: The Week in Drug Safety News

Posted by Brian Overstreet on June 9, 2017

warning.pngIt’s been a very busy week for many of us.  School’s finishing up for the kids here in California (no snow days here!), the annual ACSO conference was in full swing, the Warriors are up 3-0 in the NBA finals, and the media coverage of the Comey hearing has been non-stop.

With everything else going on, we wanted to make sure to draw your attention to some significant drug safety reporting over the past week, as we wouldn’t want to be accused of “failing to warn”!  

Stat News put out two big drug safety articles this week.  The first was titled, “Failure to warn: Hundreds died while taking an arthritis drug, but nobody alerted

Patients” and concerns the rheumatoid arthritis drug Actemra (tocilizumab).  Data provided by Advera Health contributed to the initial identification of Actemra as a potential drug of concern and our team helped to support the data analysis for the Stat News investigative team.  Stat did almost six months of verification and deep dive journalism to produce this story.  We think it’s worth a read, not only for the details Actemra, but to also understand that this situation is not all unique in terms of unlabeled safety issues.

Following on that story, Stat put out a report on the progress of Sentinel titled, “Failure to warn: An early warning system for drug risks falls flat”. As the title suggests, it wasn’t a flattering profile.  They found that FDA has invested over $200M in Sentinel and has very little to show for it over the past 7-8 years.

Via those stories, we were also alerted to an interview Medscape published a couple of weeks ago with Dr. Gerald Del Pan, the director of the Office of Surveillance and Epidemiology at the FDA's Center for Drug Evaluation and Research.  We found this discussion enlightening, especially the areas where Dr. Del Pan discussed the application of both FAERS/MedWatch and Sentinel.  He said, “We've always said that Sentinel is another tool in the toolbox. One feature of postmarket safety is having systems to detect the unexpected. MedWatch is the system that allows us to do that. Right now, our use of Sentinel is limited to evaluation of signals of safety. It does not generate signals. These are complementary approaches and we don't expect Sentinel—or anything else, for that matter—to supplant the MedWatch program. Slightly over half of the safety reports that we generate are the result of adverse event reports.”

Taken together, these three articles provide a deep look into the current state of drug safety and post market surveillance. They highlight a number of areas where improvement is needed and should open the door for constructive discussion by all of those involved.

We hope you’ll take a few moments to review the articles if you haven’t already and we look forward the discussions that follow.

Topics: Drug Safety

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