Happy New Year!
While you were hopefully enjoying a restful holiday break, the AdverseEvents analyst and tech staff were chained to their desks working on new product developments and data improvements for our AdverseEvents Explorer platform.
One of those that I’m most excited about is an improvement to our RxSignal tool. RxSignal is an algorithmic program whose primary goal is to identify approved drugs that we believe are likely to come under FDA review for safety related issues. A couple of months ago we published a list of twenty-eight of those drugs. Since then, the FDA has issued a safety warning on one of them (Onfi) and we continue to monitor the rest for changes and updates.
As we started to think more broadly about this application, it occurred to us that we should be using the same technology to screen all of the approved drugs for specific instances of unexpected adverse events. That is, to find all of the situations where a drug is showing an abnormally high rate of a serious side effect that has not previously been identified and associated with that drug. That’s a lot of drugs and a lot of side effects to review.
We know it sounds presumptuous of a little start-up company in northern California’s wine country to think that we can find drug safety problems that the established medical industry has missed. But the limitations of the current drug approval and clinical trial processes are well known (don’t take our word for it, watch this great TedMed talk) and need to be better supplemented with real-world usage monitoring. Sort of like democracy, the current system isn’t perfect. It’s just the best we’ve got.
It’s a monumental task that included, among others things, manually checking over 17,000 individual side effect findings to see if they’ve been previously documented. Fortunately, the hard work, lack of sleep, and increased coffee intake has been well worth it.
Later this month we’ll be rolling out our findings on the AdverseEvents Explorer site. As a teaser, we made this feature available over the holidays for the top 100 drugs we track. If you’re not already a client, contact us here for a free 7-day trial to see how this system works. For our existing clients, we hope this expanded feature will give you greater insight into the safety risks of well-known and widely-used medications.
And don’t worry. We plan to give our team a few hours of rest before we send them off on their next major drug safety quest.