Thanks to all of our readers for a great 2015. Below is a top 10 countdown of Advera Health's most read blog posts of 2015.
There is a tremendous amount of data available – everything from the FDA Adverse Event Reporting System (FAERS) to claims, EHR, social media and patient forum data -- all of which have the promise to add a significant layer to identifying drug safety concerns, and all of which in some form should be considered as potential data sources.
Over the past five years we’ve grown from a concept, to an actual product, to an actual company with employees and clients, to an actual company with lots of employees in three locations serving up multiple product offerings across varied market segments. While many, many things changed during that growth, one thing did not – our name. That changed this week. On Tuesday we announced that AdverseEvents is now Advera Health Analytics.
8.) To Dare Is To Do
In the little bit of downtime we had in London, my co-founder Bob Kyle and I had the opportunity to go see a soccer (FOOTBAL!!) match at White Hart Lane between my beloved Tottenham Hotspurs and Liverpool.
The Spurs’ motto is “To Dare Is To Do” – and I think that’s just as applicable to Advera Health Analytics. It’s taken quite a bit of daring to get to this point and we’re just getting started. The vision we have goes well beyond the mountain of work we’ve already done. We have plans to integrate more critical datasets into our analytics platform, to create and refine new and innovative ways to extract actionable intelligence from those data, and to continue to build out a world class team.
The real question we should all be asking is not about the two thirds data that are available but the third hidden-away. What is being excluded from public view? And why? One would assume and hope that the FDA would not approve a drug if the unpublished studies it has access to, were grossly negative, but you have to wonder why a company would choose not to publish data, particularly in a political environment where “transparency” is the word of the day. We are willing to go out on a limb and say that they did not NOT publish superior efficacy and safety results.
his result was a surprise, however, an even bigger surprise were the reasons that the panelists provided the thumbs down -- unknown harms. A direct quote from the ICER team was that although they only gave the PCSK-9’s a 10% chance of a negative net health benefit and no adverse events seemed concerning, “…we said the same thing with Abbvie’s hepatitis C drug.” Several panelists said that they needed to see the “adverse events from public monitoring” and the outcomes trials that are due in 2017 before being able to make a net health benefit decision.
This is an astonishing approval rate, especially when considering that in 2008 only half of the drugs submitted to FDA were approved. Of course, there are a lot of explanations for why this is occurring. Matthew Herper, staff writer for Forbes that covered the analysis, provides nine such explanations in a follow up article to his original post about the analysis. From his explanations the reason we found the most striking, was his last: In the current political environment, the agency is approving drugs it shouldn’t.
Advera Health Analytics’ reputation has been built on providing our clients with timely and actionable insight from vast drug safety datasets. And there are many challenges to providing these services, including how to clean and optimize the messy core data and how to build analytic tools that extract value from those data. But one of our biggest challenges is making sure that we have the most up to date data possible. Without that, we’re like a racehorse stuck at the gate – all raring to go but unable to step forward.
For those of you not already following along, the debate over high drug prices first came to light with the approval and marketing of Sovaldi and its $84,000 price tag. There have been a number of other new, high-priced drugs that have come to market over the past year with less furor, including Sovaldi’s successor Harvoni and its $94,500 treatment cost. But the brewing tempest exploded into full-fledged Cat 5 tornado levels over the past couple of weeks with the news of Turing Pharma’s decision to raise the price of its Daraprim by some 5,000%. Part of that escalation in outrage was due to Turing’s unorthodox CEO and his “unique” media dealings.
This past week, our team of analysts released a Drug Safety Monitor note to our clients comparing the safety of AbbVie’s Viekira Pak to Gilead’s Sovaldi / Harvoni. What we found was that while both drugs are indeed equally efficacious, the safety profile of Viekira Pak appears to be inferior to that of Sovaldi.
Confident in our conclusion that Harvoni was the safer choice, we still reiterated our core belief that only with close post-marketing monitoring will the true safety profile of the drugs be ultimately revealed. And “close post-marketing monitoring” we did. Since January 2015, the Advera Health team has submitted 7 separate Freedom of Information Act (FOIA) requests for these three drugs, providing our clients with virtual real-time data, and over 11,000 case reports in these past 9 months, all of which were made available to our clients before FDA publicly released the data on its’ own.