New technologies that support postmarketing patient communication and safety surveillance can produce a mountain of data. But are these new tools creating value or just more noise?
YourEncore recently convened a panel of experts to discuss this topic after the 2015 Regulatory Affairs Professional Society (RAPS) Convergence conference in Baltimore, Maryland. To watch the panel discussion, click here.
YourEncore Executive Partners, Peter J. Pitts, former FDA Associate Commissioner, and Dr. Don Therasse, former VP of Global Patient Safety and Global Medical Affairs at Eli Lilly & Co., shed some light on the topic.
Peter Pitts: There is no such thing as a risk-free product. From a regulatory perspective, when you’re looking at outcomes, we’re learning the difference between efficacy in a clinical trial and effectiveness in the real world and how to capture and compare the data sets.
The general consensus is that MedWatch captures around 10 percent of adverse events. That’s probably high. But even if it’s spot on, it’s remarkably and dangerously low. How are we capturing and reporting substandard pharmaceutical events when a drug doesn’t necessarily have an adverse event but just isn’t working? API problems, excipient problems, manufacturing problems—from a lexicon perspective, unless you can put a name to it and put systems in place, it’s anecdotal. If we want to bring drugs to market faster with truncated clinical trials, we’re going to need a much more robust post-marketing proposition.
There are a lot of ways to collect data. Social media is one that has caused problems. The signal to noise ratio issues are profound, but we can’t ignore it because within all that noise there are gems that we must capture. The challenge is how to put robust modern pharmacovigilance or pharmacoepidemiology programs in place for established drugs and decide who leads the effort. We need to do a better job of capturing and sharing data in real time. This requires better staffing and an openness to finding new things.
A couple of years ago I was talking to a pharmaceutical company in New Jersey, and someone said to me, “We don’t use social media because we don’t want to find adverse events.” We must embrace negative information, because it’s happening in the real world.
Don Therasse: Everybody talks about how we can do these things and manage the entire post-approval safety environment more effectively and efficiently. The fear is not that we will find new information; it’s that we would overwhelm our current systems and capacity with poor quality information – and just generate more noise as opposed to real signals. That’s the primary concern about the social media space.
The goal of the pharmacovigilance enterprise is not to simply generate more signals; it’s to generate better signals and to apply our finite resources to identifying safety issues and implementing programs to help mitigate them. In terms of regulatory convergence, or divergence in this area, we need work not only in this and other areas that define sources of information for signal detection, but also for how we manage the data, how it’s reported, how you’re inspected and how you implement your risk mitigation programs. Everybody has the same goals, but everyone seems to want to put their own spin on it which causes redundant effort and diverts way too many resources from the important work at hand creating a very inefficient system.
There are many good ways to advance the science. At the same time we have to be disciplined and willing to give up older, less effective activities. There are finite resources on both industry and regulatory sides, and we’re diverting too much of our attention to nonproductive activities at the expense of fully implementing powerful new tools.
Pitts: We have a tool at our disposal that is poorly used, which is physicians. How many hours do medical students spend learning about drug safety management and adverse event reporting? None. How much time do physicians spend in their daily practices thinking about adverse event reporting? How friendly is the MedWatch system? Obviously, the first mission of doctors is to address their patients’ immediate needs. Once that’s done there is an obligation to share information that can advance the science and ultimately help to prevent similar issues for future patients. We need greater awareness and more effective, user-friendly processes to encourage and enable them to do so.
