The Adverse Event Data Advantage

Towards the end of 2011, my business partner’s wife became sick from an adverse drug event. We did what most people would probably do in the same situation – we turned to Google. But even with a million hits, we still didn’t have clear explanations as to why it had happened.

Here in the US, we see drug advertisements all the time, and although they list possible side effects they do not answer the key questions. What are the odds that I will experience that side effect? What happens if I do experience that side effect? How quickly will I get better? Will I die? Patients need this information. And yet little attention has focused on this area. At the time of the illness, my business partner (Bob Kyle) and I discovered that the FDA had a massive data set on adverse drug events. Unfortunately, it wasn’t making that data easily accessible or allowing people to run queries against it.

In my view, there are tremendous benefits to cleaning this type of data up – not just for patients, but also for pharma companies, hospitals and insurers – so that’s what we did. Bob and I have a lot of experience in healthcare data and research reports. We are the founders of Sagient Research and, at the time of the illness, we were in the process of selling the company to Informa. Because of our background, we thought that some research into adverse drug events would be a nice little side project – the aim was to quickly throw the project together and put up a website. How ignorant our thinking was at the outset! We quickly realized the importance of adverse drug event data and the project ballooned.

We formed a company called Adverse Events (although we changed the name in 2015 to Advera Health Analytics). It took us over 18 months to dig through the FDA’s adverse event database and we managed (with a lot of hard work) to create a clean data set against which we could run queries against. We also developed an algorithm that maintains the cleanliness as we bring new data in. At the start, we were just using the FDA database but now we’re also incorporating other data too.

Most people don’t like to think too deeply about adverse events – and I think that pharma companies would prefer that all the negative information about their drugs was not known at all (for obvious marketing reasons). Indeed, when our company was called Adverse Events, we soon found that some companies were scared by the name alone! When we attended trade shows, people would come to the booth, stop, tell us that they weren’t allowed to talk to us and walk away! There were bigger reasons for the name change too – most importantly, our business has since expanded to cover much more than adverse events data.

But when it comes to adverse drug events, the data is already publicly available. At times it can be difficult to find, but it is there and if pharma companies get involved in digging through this data they will discover a number of benefits. For example, a company can conduct concert studies or reviews on the data to compare the safety of their new drug with drugs that are already on the market. They could also do the inverse. Such studies produce verifiable and validated results that can be published or taken to a conference and presented as a poster. It’s also possible to use adverse events analytics to predict FDA alerts on drugs – we predict correctly about 70 percent of the time. And though companies may not want to deeply consider such facts, it’s better to have a heads up on any potential changes. Although our journey started with a patient, I believe analytics actually benefit patients the most through a top-down approach, so pharma companies, hospitals and insurers need to get stuck in.