Q1 2009 AERS data released today

FDA released the Q109 AERS data today.

Initial upload into FDAble looks like everything was okay.

Interestingly, there are ~111,000 reports in this release compared to ~121,000 for the previous quarter. Not sure how significant this decrease is (is it seasonal? is it just noise? is FDA weeding out duplicates?). Will take closer look later....

The Food and Drug Administration isn't able to reliably determine how much money it needs

WOW. Sister-in-law sent this to me...

By JENNIFER CORBETT DOOREN

WASHINGTON -- The Food and Drug Administration isn't able to reliably determine how much money it needs to regulate medical products because, among other things, its staff can't track all the adverse-event reports it handles, according to the Government Accountability Office.

Full story here.

FDAble's Side Effect Check now available in iTunes App Store

Can be had here.

FAERS - AERS, but Fancier

Someone at FDA sent this to me recently (see below). It's an email sent around from within the FDA announcing a new Adverse Event Reporting system (sort of).

Emphases are mine. Editorial comments are mine, too.

Spoiler alert: They forked over $$$$$ and went with Oracle.

Bioinformatics Board (BiB) News

Post Market Safety BRB Announces Selection of Vendor[We've decided to shop at Barney's. Can't tell you what we're buying just yet, but it's gonna be FAB!] for New Enterprise Adverse Event System

The Bioinformatics Board (BIB) News provides FDA employees with an update on the activities and progress of the BiB. This month’s news focuses on the Post Market Safety BRB and the selection of the Adverse Event System Vendor. For more information about the BiB or the contents of this message, please contact your BiB representative or email the Bioinformatics Board, bioinformatics@fda.hhs.gov.

Post Market Safety Business Review Board Announces Selection of Vendor for New Enterprise Adverse Event System FDA’s Bioinformatics Board and the Post Market Safety Business Review Board are pleased to announce a significant milestone for the Agency. After an extensive analysis of FDA scientific needs for the management and analysis of post market product safety reports, and an evaluation of leading industry tools, the FDA Adverse Event Reporting System (FAERS) Program has selected Oracle AERS[$$$] (Adverse Event Reporting System) as the new tool for FDA staff[guess who's not getting access to the data juuuust yet...?] to efficiently[you wouldn't believe what we were doing before] analyze post market safety reports in order to identify potential product safety problems.

Selection of the new FAERS tool represents a significant landmark for the Agency. With the selection of an advanced tool that all centers and offices can leverage, the Agency can now focus on implementing processes for sharing post market safety data across our product centers as well as advancing the science of post market report analysis. Achievement of this milestone represents the efforts of numerous individuals from across the Agency over several years[wow. just...wow]. While in many ways this is just a beginning, it is important to recognize our progress towards meeting the goal of providing modern tools necessary to address many post-market surveillance needs. Selection of Oracle AERS[What? no love for MySQL? They're about to be subsumed by Oracle, too, ya know.] positions the Agency for success in this complex and dynamic arena.

We expect the initial users in CDER and CBER to receive training and begin using the new system as early as fall 2009[but don't quote us on that] with additional users being trained and brought on over time. CDRH users are expected to begin using the tool in 2010, and additional centers and offices expected shortly thereafter.

VAERS Update...this time with feeling

The FDA (or is it the CDC? Or is it Health & Human Services? Can't really tell....) just updated its Vaccine Adverse Event Reporting System (VAERS) dataset (April 13, 2009).

What they haven't bothered to note is that they've also changed the structure of their dataset.

VAERS data used to come packaged as 2 CSV files--one called VAERSData.csv and one called VAERSVaccine.csv.

VAERSData.csv used to contain 20 slots per row for symptoms associated with each vaccine adverse event.

In the database world, one says that there is a 1-to-many relationship between a VAERS report and the Symptoms associated with that report.


And day 1 of any remedial Database management course will inform you that because of the 1-to-many relationship, you should separate the VAERS record from the Symptoms records and link each symptom back to its report via a foreign key.

The reason for doing this is that 20 slots for symptoms *may* seem like more than enough slots for any case that you'll ever come across, but at some point, some hypochondriac is going to slip in 21 symptoms and totally screw with your file.

Well, 19 years later, the VAERS folks have finally given the Symptom data its own csv file, appropriately titled VAERSSymptoms.csv. They didn't bother to tell anyone that they did this...and I had to tinker with my parsing algorithm last night to adjust for the changes, but the discerning pharmacovigilantes among us were able to figure it out when we asked ourselves

"Why are there 3 csv files per year now when there used to be 2? And why haven't they updated their file explaining the structure of the VAERS files?" As of this writing, the most recent revision of the VAERS explanation is June 2007.

Ah yes...lest I forget...as of this writing, the Zip file containing all of 2008's VAERS data is contaminated with 2009 data. I think that's just to keep everyone on their toes.