On this past Sunday’s 60 Minutes, astronomer Mike Brown made a bold prediction – that within three years the scientific community would identity a new, large 9th planet located in the outermost area of our solar system. Even more astonishing was how certain he was about that prediction, “I would say at this point, I am certain….that’s a rare thing to say – for a prediction for a scientist. And I’m willing to say it.” Mike Brown has some credibility in this area, as he’s the guy who figured out that Pluto wasn’t a planet after all. Maybe it’s his own guilt over breaking every school-kid’s heart that’s driving his prediction, but both his prediction and his certainty really fascinated me. If you haven’t watched the report, I’d urge you to do so (link is here).
Brown’s certainty got me thinking about my own predictions for 2017 – whether I had any and about my level of certainty. The one that I keep coming back to, and it’s been percolating for a while, is a prediction that 2017 is going to be the year that pharmacovigilance finally breaks out of the realm of data collection and number crunching and makes it into the mainstream conversation and consciousness. I’m thinking along the lines of what we saw with drug pricing in 2015.
Call it the Year of Drug Safety.
How do I arrive at that prediction and what’s my level of certainty? Well, I’m not as certain as Brown is about his 9th planet. But if you watch the show, you’ll see that his prediction is based on circumstantial evidence and math. We don’t yet have telescopes powerful enough to see “planet 9” so far out in the solar system. But the astronomers are able to see a whole series of Pluto-sized bodies pulled in symmetrical orbits around “something” that’s just out of the range of view. If we rationally exclude the possibility that it’s not the Death Star, then it seems likely that there is a planet out there affecting the gravitational pull – and a rather large one at that.
So, along the same lines, here’s my circumstantial evidence leading to my prediction that 2017 could be the Year of Drug Safety:
- We have many pharma clients actively working on various innovation projects within the pharmacovigilance department. These include moving away from just signal detection and case reporting to active signal management as well as holistic interactions with all facets of the organization – from trial design to market access. These changes haven’t sprung up overnight, but they seem to be all coming to fruition around the same time with roll outs already underway or imminent. The renewed interest and investment within the industry is long overdue and should lead to significant advancements in tools, analytics, operations, efficiencies, and the impact of pharmacovigilance professionals.
- The media is picking up interest in drug safety as an overall story. We get media inquiries all the time about specific drugs or other narrow topics. In the past couple of months, I’ve had multiple inquiries from large media outlets starting to do deep dives into the state of the drug safety safety-net in this country and how we search for – and hopefully prevent – the next major drug safety crisis. These journalists are sniffing around because they’re realizing that there’s a significant untold story here about what happens to drugs once they make it out of clinical trials. Those of us who work in this field know the facts all too well, but you’d be amazed how unaware most lay people are about the risks.
- Interest around drug safety is emerging in many unusual places. I’ve spent the past week shuttling through our crazy rainstorms down to San Francisco for the JP Morgan healthcare conference. This annual commercial schmooze-fest is about the last place you’d expect to find people interested in talking about the relative downer of drug safety, but every single person I spoke to was engaged on the subject and had a specific line of interest for their organization. Pharma, VCs, consultants, public and private equity investors, etc. They all are opening their eyes to the risks – and the potential rewards – of drug safety.
Is all of that enough for me to say with certainty that this is it – Is 2017 the Year of Drug Safety? I’m close, but I’m still not as certain as Mike Brown is with his 9th planet prediction.
What’s holding me back is the sad reality that I think we’re going to have to endure another Vioxx-like disaster before drug safety is really back in the mainstream consciousness. Just like in 2015 with drug pricing, there needs to be a case so outrageous and a figure so villainous that we all can’t help but stop and pay attention. Ironically, if we’re all doing our jobs properly that just shouldn’t happen.
I think 2017 is going to be a big and important year for drug safety and pharmacovigilance professionals and we’re looking forward to supporting our clients in all of their endeavors. But, the Year of Drug Safety? Your guess is as good as mine.
What do you think? Let us know in the comments.
Or if you’re planning to be at the DIA Pharmacovigilance and Risk Management Strategies Conference in Washington at the end of this month, reach out to us here to schedule some time to chat. We’d love to hear your thoughts and plans for 2017.
Brian M. Overstreet, President, Advera Health Analytics, Inc.