The RxView Blog

Real world data, analytics, and insights for healthcare decision makers

Advera Health Analytics, Inc.

Failure to Warn: The Week in Drug Safety News

By Brian Overstreet on June 9, 2017

It’s been a very busy week for many of us.  School’s finishing up for the kids here in California (no snow days here!), the annual ACSO conference was in full swing, the Warriors are up 3-0 in the NBA finals, and the media coverage of the Comey hearing has been non-stop.

With everything else going on, we wanted to make sure to draw your attention to some significant drug safety reporting over the past week, as we wouldn’t want to be accused of “failing to warn”!  

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Topics: Drug Safety

How is Evidex Different from Traditional Signal Detection Software?

By Jim Davis on May 26, 2017

When first talking with drug safety departments, we often get asked how our platform is different than systems that they already have in place. The key difference between traditional signal detection software and a drug safety evidence aggregation platform comes down to the types of data they each support, the flexibility in which those data are supported, and the much broader use cases available through an evidence aggregation platform.

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Topics: Drug Safety, Pharmacovigiance 2.0

Post-Marketing Drug Safety and Pharmacovigilance Is Now More Important Than Ever

By Jim Davis on May 12, 2017

If you read this blog, you probably follow the world of drug safety closely. So I’m sure you saw the JAMA article, and the resulting coverage by the main stream media, that was authored by Downing, et al., Postmarket Safety Events Among Novel Therapeutics Approved by the US Food and Drug Administration Between 2001 and 2010.

If you haven’t had a chance to read the study yet, the results demonstrated that a third of every drug approved from 2001-2010 was subject to post-marketing action by FDA.  Even more alarming was the finding that drugs with accelerated approval by FDA during this period were twice as likely to be subject to label changes or warnings after approval. 

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Topics: Drug Safety, Pharmacovigiance 2.0

Make Hair Great Again - The Real Reason for FDA Reform

By Brian Overstreet on March 3, 2017

A personal note:  About a month ago, we published a blog post titled Drug Safety Progressives.  While 99.9% of the readers understood that this wasn’t a political statement, we did get hit with some great trolling that accused us of, among other things, pushing “Alt-Left Propaganda on a Left Wing Socialist website.”  How or why someone reached that conclusion is beyond me.  Regardless, I’m dedicating today’s blog post to those 0.1% of our readers who troll for an internet fight.  I’m confident that the rest of you will enjoy it too.

We know that with the fake news circulating these days, you may have missed the most important breaking story concerning President Trump in February.  That’s right, he’s taking something to maintain that famous hair – Propecia.

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Topics: Drug Safety, FDA

A Big Data Stumble in Healthcare

By Brian Overstreet on February 24, 2017

This week marked the annual HIMSS Conference.  HIMSS, Healthcare Information and Management Systems Society, is the big annual gathering of IT firms trying to market their wares into healthcare systems, pharmaceutical companies, and health insurers.

While usually a time for big partnerships, acquisitions, deployments, and new client wins, this year’s HIMSS kicked off in a rather inglorious manner.  On Sunday news broke that world-renowned cancer center MD Anderson had discontinued their partnership with IBM Watson.  After a string of big wins by the Watson team, this appeared to be the first – and certainly the largest – setback.

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Topics: Drug Safety

Drug Safety Progressives – The Rise of the Pharmacovigilante

By Jim Davis on February 2, 2017

The United States is a polarized place right now. Democrats vs. Republicans. Liberals vs. Conservatives. President Trump vs. the world. The divide runs deep and battle lines have been drawn. And while there is no escaping this highly publicized political chasm, there is another fight being played out in the shadows… The Drug Safety Progressives vs. the Drug Safety Conservatives.

I was at the DIA Pharmacovigilance and Risk Management conference last week, fittingly taking place in Washington D.C right after the inauguration and the women’s march.  The division was obvious.

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Topics: Drug Safety

Advera Health Partners with APCER Life Sciences to Connect Drug Safety to Health Outcomes

By Brian Overstreet on January 26, 2017

We were very excited this Monday to announce a new partnership with APCER Life Sciences, a global provider of safety, medical, regulatory, and technology services to the pharmaceutical industry.  Working with the dedicated professionals at APCER will enable us to expand our reach into the safety and pharmacovigilance departments at pharmaceutical companies globally. 

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Topics: Drug Safety, HEOR

Real-Time Drug Safety Analysis with Evidex Alerts

By Bob Kyle on January 20, 2017

This week we launched Evidex Alerts, a new feature that provides our clients with real-time updates on the latest impactful drug safety news. This is a project that our development and analyst teams have worked on diligently for the last three months, and I am excited to announce that it became a reality this week. 

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Topics: Drug Safety, Clinical Evidence, Evidex

Will 2017 Be The Year of Drug Safety?

By Brian Overstreet on January 12, 2017

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).

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Topics: Drug Safety

Working Toward a Cure: The Foundation for Sarcoidosis Research

By Jim Davis on January 5, 2017

In November 2016, I was honored to be asked to join the Board of Directors of the Foundation for Sarcoidosis Research (FSR). The foundation began in 1999 as a grassroots organization, and now has expanded their efforts and impact to become the leader in supporting sarcoidosis research. I'm looking forward to using my experiences both as a sarcoidosis patient and in drug safety to contribute to the mission. Please visit www.stopsarcoidosis.org for more information. 

I originally wrote the post below for the FSR blog. The original can be seen here

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Topics: Drug Safety, Drug / Indication Information

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