A few weeks ago, I was on a call with one of our Business Development Managers, explaining the details of our proprietary analytics to a Pharmacy Director at a health plan that we were trying to turn into a client. We were walking through our RxSignal technology for a particular drug and the executive said to us, “This looks great but you can’t possibly predict what the FDA is going to do in the future”.

I responded, “Of course no one can predict every future drug label change that the FDA makes with 100% certainty, but we can get pretty close—as someone who makes very important decisions, that not only affect your organizations bottom line, but patients’ lives, that’s a huge window of opportunity to take advantage of.“ And then he stated, “Well, if you can’t predict the future with 100% certainty, then this is something I won’t be able to use.”

I jokingly told him, “If I could predict the future with that kind of accuracy, do you really think I would even be talking to you right now?” Everybody on the phone chuckled but I knew at this point we were dealing with a member of the old guard that couldn’t see the bigger picture. He was limited by not only an unrealistic business goal of perfection, but of the unwillingness to see major advancements in big data. And once again we saw the divide that exists in the healthcare industry between those forward thinking organizations who want as much accurate, actionable data as possible and those who’d rather turn a blind eye because the status quo is just easier.

The irony of that phone call is that we do continue to “predict the future” every day. And every day our clients use our analytics to take preemptive actions that save them money and improve patient outcomes.

Just last week, the FDA issued a warning about the link between a class of diabetes drugs called sodium-glucose cotransporter-2 (SGLT2) inhibitors and ketoacidosis, a serious condition where the body produces high levels of blood acids called ketones that can require hospitalization. As you can see from the screenshot below, we had an active signal for this safety issue for the SGLT-2 Inhibitors prior to this announcement by the FDA, including AstraZeneca’s Farxiga:

 

Farxigan RxSignal

 

Over the last several months, we have been closely monitoring the diabetes space as there are several new classes of drugs (SGLT-2 Inhibitors, GLP-1 agonists, and DPP-4 inhibitors) whose true safety profiles are still being determined with the evolution of post-market adverse event data. Because of this focused interest, we have been submitting continual Freedom of Information Act (FOIA) requests to make sure we have the latest case reports on all of these drugs, that have not yet been publicly released via the FDA website. With the help of this FOIA data, we became aware of several ketoacidosis cases over the last few months and were able to generate safety signals prior to FDA announcement.

Another example of AdverseEvents’ predictive skills is the recent label addition of the link between the kidney cancer drug Votrient and Retinal detachment/tear. As you can see from the screenshot below, AdverseEvents had an active RxSignal for this safety issue prior the label change.

In fact, we have had an Active RxSignal for Votrient since 2013. This is a classic example of why RxSignal and AdverseEvents Explorer in general is valuable to our clients.  

Safety issues often get lost in the internal bureaucracy of the FDA and its negotiations with manufactures. Relying purely on a drug’s label or its clinical trials provides an incomplete, inaccurate and untimely understanding of a drug’s true safety profile. It is shocking to me that there are so many payers and providers still out there who think they can provide the most cost-effective and beneficial outcomes for the patients they are responsible for while waiting more than 15 months before they even hear about issues like these.

 

Votrient rxsignal

 

AdverseEvents already does a great job of “predicting the future”, and we strive for as close to 100% accurate as we possibly can. Our team of gifted analysts and programmers work feverishly to refine the RxSignal process even further to eliminate some of the safety issues that don’t always get the attention of the FDA. In the next few weeks, look out for some exciting new announcements in this area.

Knowing the future actions of the FDA before your competitors provides an unprecedented opportunity to alter existing product strategies, formularies and communications plans. In this window of time you are afforded a chance to make substantial financial and healthcare decisions that will affect your bottom line and most importantly patient outcomes.

What could you do if you knew the future actions of the FDA? Register for a free 7-day trial of AdverseEvents Explorer to find out.

 

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Robert Kyle

Robert Kyle

Chief Product Officer

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Bob Kyle

Written by Bob Kyle