June 15, 2018

Depression as a Drug Side-Effect: A Quick FAERS Analysis

A study published Tuesday in the Journal of the American Medical Association found that people who take at least one of the 200 drugs that list depression as a side-effect are, in fact, more likely to be depressed. The study, which included 26,192 adults who participated in the National Health and Nutrition Examination Survey, does not prove a causal effect, but the association is striking. 

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December 1, 2017

Analysis of a FDA Safety Signal: DPP-4's and Rhabdomyolysis

Recently the FDA published the Q2 2017 version of Potential Signals of Serious Risks / New Safety Information as identified by the FDA Adverse Event Reporting System (FAERS).

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March 10, 2017

ICER Underestimates Adverse Event Rates and Costs for Multiple Sclerosis Medications

 

On March 6th ICER released their final Evidence Report on Multiple Sclerosis medications. The conclusion was that every MS medication, except for Lemtrada, do not provide enough value to justify their prices. As with every ICER report that is released, the pharmaceutical manufacturers refute the findings and tout their R&D expenses and the very real burden of bringing life saving drugs to markets.

I’m not looking to start a debate on the merits of either ICER’s or the manufacturers’ arguments in this post. Taking my position on the fence, I can say that I believe ICER provides a valuable, independent view into value, but at the same time pharmaceutical companies should expect to be able to be reasonably compensated for their efforts.

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February 9, 2017

Using FAERS Data and Clinical Evidence to Compare HER2+ Antagonists

Recently, Advera Health released a comparative safety report of the HER2+ Antagonists. In this drug review, we analyzed FDA Adverse Event Reporting System (FAERS) and clinical trial data to better understand how the drugs in this class stacked up.

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January 5, 2017

Working Toward a Cure: The Foundation for Sarcoidosis Research

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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July 8, 2016

Chronic Underreporting of Clinical Trials


Well, now we’re getting somewhere!

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June 16, 2016

How to Make Sense of the ADA Conference Data Deluge

Every June, on the heels of the ASCO annual conference, comes the American Diabetes Association (ADA) annual conference, with a data deluge that is difficult for even the most diligent industry watchers to keep up with. At time of writing, it is only midday on Tuesday and there are already huge headlines from the conference.

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May 20, 2016

3 Reasons a Clinical Evidence Database for Multiple Sclerosis is Important


Oftentimes it’s hard for me to see the forest through the trees. Being responsible for the commercial outcome of what we are working to accomplish at Advera Health with an incredibly talented, albeit small, team can be daunting at best.  At worst it is completely insanely chaotic. Ensuring sales forecasts are accurate for board and investor meetings, directing the marketing strategy for product launches like this week’s announcement of our multiple sclerosis coverage, and working out the details of big partnerships like the one we will soon be announcing with a large, national group purchasing organization (GPO) requires a lot of attention to detail, acutely managed with a long to-do list.

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May 6, 2016

The Comparative Safety of Multiple Sclerosis Medications – A 2016 Update

If you subscribe to our monthly RxView Newsletter, then you probably saw the announcement that later in May, annotated data from curated clinical trial results for Multiple Sclerosis (MS) medications will be available in Evidex. Our coverage will include all approved drugs, as well as those in phase II development and above.

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April 29, 2016

Show Me The Evidence!!!


The Associated Press had an interesting article last week titled “Why So Few Patients Get the New Cholesterol Busters.”  In it, the author examines why the launches of the new PCSK9s (Praulent and Repatha) have been so slow and financially lack-luster.

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