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.
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.
Topics: Hepatitis C
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.
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.
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.
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