The RxView Blog

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

Advera Health Analytics, Inc.

Canada’s March Toward Mandatory Reporting of Adverse Events by Providers

Posted by Brian Overstreet on July 14, 2017

Canada has long had a more open system for reporting and searching adverse drug events.  They provide an easy to use online form for healthcare providers and consumers to make direct reports, which contrasts significantly to the cumbersome reporting form provided by FDA here in the U.S.   They provide a web-based search tool that enables anyone to search through adverse event reports submitted to Health Canada.  Nothing like that exists from FDA in the U.S.

Now comes word that Canada is taking a step toward something that we’ve long believed to be a crucial factor in improving and increasing adverse event reporting – requiring reporting from healthcare providers. 

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Topics: FDA, adverse drug event reporting, Canada

Make Hair Great Again - The Real Reason for FDA Reform

Posted 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 Crystal Ball for FDA Action: How we Validated RxSignal

Posted by Dr. Keith Hoffman on March 11, 2016

We are pleased to report that our latest major publication, “A Pharmacovigilance Signaling System Based on FDA Regulatory Action and Post-Marketing Adverse Event Reports” was released this week in the esteemed journal “Drug Safety.”  It was published as an online-first feature and will also appear in the April copy of the print version of Drug Safety.

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Topics: FDA, FAERS, RxSignal

It’s Confirmed: FDA is Failing When it Comes to Drug Safety

Posted by Jim Davis on January 22, 2016

Recently a report by the U.S. Government Accountability Office (GAO), filed at the request of Representative Rosa DeLauro on December 15, 2015 was made public. The report’s focus was to better understand the rate at which drug applications were expedited using “fast track” and “breakthrough therapy” designations and if FDA was fulfilling its duty to properly track and analyze post-marketing monitoring for those drugs.

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Topics: Drug Safety, FDA

Mad as Hell and Not Going to Take This Anymore

Posted by Brian Overstreet on December 18, 2015

We were blown away this week by Stat News’ investigation into the blatant underreporting of clinical trials data to the federally mandated website.  If you haven’t already read this masterful piece of journalism, please do so. No, really.  Go ahead and read it.  I’ll wait.

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Topics: FDA, Clinical Trials

Could Diabetes Patients’ Safety Been Improved if the SGLT2 – Ketoacidosis Link Were Known Sooner?

Posted by Jim Davis on December 11, 2015

ashp_keith_with_poster-532765-edited.jpgReceiving Medwatch emails from FDA are an exciting thing around Advera Health. Though a bit morose, when we see that drug safety warning pop into our Inbox with FDA’s logo, we must admit to getting a little giddy. On Friday, FDA issued their second safety communication around the SGLT2 class of diabetes drugs and a serious (and very costly) side effect of those drugs, a condition called ketoacidosis. Ketoacidosis is a very serious condition that can lead to diabetic coma or even death. In this communication it was revealed that the FDA finally added ketoacidosis as an adverse event to the drugs’ labels, following an initial communication in May that they were evaluating the risk.

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Topics: FDA, Diabetes, SGLT2

Lack of Transparency is Disturbing, Unsurprising, and Validating

Posted by Jim Davis on November 20, 2015

More than a third of clinical trial drug data was not publicly reported according to a paper published last week  in BMJ Open. The study was well covered by the Washington Post, and serves as the basis for the lead author, Dr. Jennifer Miller’s non-profit, Bioethics International which will publicly grade the transparency of drug companies.

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Topics: FDA, Pharma

FDA is Slow so We FOIA

Posted by Brian Overstreet on November 13, 2015

Since 1967, the Freedom of Information Act (FOIA) has provided the public the right to request access to records from any federal agency. It is often described as the law that keeps citizens in the know about their government. Federal agencies are required to disclose any information requested under the FOIA unless it falls under one of nine exemptions which protect interests such as personal privacy, national security, and law enforcement.

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What does the FDA and Scarface Have in Common? They Both Understand Power

Posted by Jim Davis on May 1, 2014

In this country, first you get the data. Then you get the power. THEN you get the insight… That’s why you have to make your own moves.

Not quite the same as Tony Montana’s famous quote in the Brian de Palma classic, Scarface, (money-> power-> women) but the analogy can be made. In Tony’s world, those that control the money, hold the power. In the world of drug safety, those that control the data, hold the power. And not until that balance of power is shifted from a controlling few like the FDA and the pharmaceutical industry, to healthcare decision makers, can true insight be had.

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Topics: FDA, faers data

FDA Releases Updated Drug Safety Data – Announces OpenFDA… Now hold your applause

Posted by Jim Davis on March 28, 2014

Creating actionable analytics around the big data set provided through the FDA Adverse Event Reporting System (FAERS) is the backbone of the AdverseEvents Explorer software. Given the infrequency of releases in 2013, you can imagine how excited we were when we heard the news that Q1 2013 data were finally posted for download. While probably not surprising, self-described data geeks do get excited about data.

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Topics: FDA, AdverseEvents Explorer, FOIA

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