The RxView Blog

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

Advera Health Analytics, Inc.

Dr. Keith Hoffman

Recent Posts

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

Drug Safety Perspectives on Hepatitis C

Posted by Dr. Keith Hoffman on February 27, 2015


In the past two weeks AdverseEvents has been invited to share our drug safety analytics and insight on two different panel discussions focused on the new hepatitis C medications. Two things really struck me about this.

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Topics: Hepatitis C

Hepatitis C: why side effects of treatment are a particularly big deal

Posted by Dr. Keith Hoffman on June 12, 2014

Hepatitis is a fancy word for liver inflammation. Sounds just somewhat serious, right?

Wrong, infections that cause Hepatitis can be a very grim business. In fact, they are responsible for one of the world’s largest healthcare burdens.

Hepatitis can be caused by different viral infections that are designated by the astonishingly creative nomenclature of A, B, C, D, and E. Hepatitis C (HCV) is what we will focus on today. ~200 million people carry this virus around inside them, including 3-4 million Americans. Ten times as many people are infected with HCV than HIV.  It is the most common blood-borne viral infection in the world and is responsible for substantial amounts of morbidity and death.

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Topics: Hepatitis C, HCV, treatment, side effects, Sovaldi (sofosbuvir)

The Disconnect Between Clinical Trials and Real-World Side Effects

Posted by Dr. Keith Hoffman on November 21, 2013


In order to increase the likelihood that drug efficacy signals can be detected during clinical trials, pharmaceutical developers purposefully enroll subjects who are expected to help achieve the best possible results. Potential clinical trial participants are subjected to rigorous inclusion and exclusion criteria. Subjects that pass these selection processes and are ultimately enrolled in the trial, therefore, end up being a relatively homogenous group.

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Topics: FDA, safety data, Clinical Trial, post FDa approval

Can Psychotic Side Effects be Triggered by the Drugs My Child is Taking for ADHD?

Posted by Dr. Keith Hoffman on October 2, 2013
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In a previous post, When the FDA Approves a Drug, That Means It's Safe, Right? I discussed why clinical testing prior to FDA approval does not, and cannot, elucidate the full side-effect profile of a drug. Many side effects, including some that are quite serious, are only observed after a drug has won approval.

As with most drug classes, the above point holds true for Attention Deficit Hyperactivity Disorder (ADHD) medications. This is a growing public heath concern, particularly because more and more sub-populations of patients are being prescribed these drugs, and a significant amount of children take them.

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Topics: Drug Safety, FDA, Adderall, Daytrana, Strattera, ADHD, Provigil, Concerta, Focalin, Ritalin

When the FDA approves a drug, that means it is safe, right?

Posted by Dr. Keith Hoffman on September 13, 2013
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I hear that question all the time, and the answer is “no.”

The mantra that is repeated over and over about the FDA drug approval process is “for a drug to win approval it must prove to be both safe and efficacious by rigorous clinical testing.” To a large extent that mantra rings true on the efficacy side of the equation, but with regard to safety, FDA-mandated clinical testing regimes oftentimes fall short.

Human complexity and why it is an issue for drug safety
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Topics: FDA, vioxx, baycol, meridia

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