Innovation in Post-Launch Surveillance and Pharmaco-Vigilance (Part Two)

author: Isaac Samuel Kohane, Center for Future Civic Media, Massachusetts Institute of Technology, MIT
author: Névine Zariffa, GlaxoSmithKline
author: John Glaser, Partners HealthCare System
author: Randall Lutter, U.S. Food and Drug Administration
author: Joanna F. Haas, Genzyme Corporation
published: June 4, 2013,   recorded: August 2005,   views: 2961

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These panelists describe struggling to transform their approach to drug safety, while acknowledging the need to regain public trust after troubling episodes involving drug side effects.

Névine Zariffa points out that “no clinical trial program known to man will ever help predict every single instance of everything that might happen in the big, wide world.” But, she wonders, “What can we do better to link up what we discover through the clinical trial process relative to what happens in the real world?” One idea: a Center for Biomedical Information SWAT team to deal with FDA drug alerts.

“The whole country is moving slowly, but moving” toward capturing patient records, imaging information, and even genomic and proteomic data electronically, reports John Glaser. Partners HealthCare holds a clinical data repository for 3.3 million people, from academic medical centers to community hospitals. This kind of database may help track “consistent drug interactions” as well as notify patients at risk when a side effect becomes apparent.

“Even if you think that drug reviewers look at newspaper accounts, if they focus more on drug safety, wouldn’t that slow review times? The answer is no,” claims Randall Lutter. He says that the FDA has not slowed approval times to appease a worried public, nor has it sacrificed science to please manufacturers eager for rapid drug approval. Rather, the agency’s concerned with getting accurate warnings on drug packages at the time of their launch, and disseminating information earlier to the public.

In the early 60s, says Johanna Haas, when the use of Thalidomide was linked to terrible congenital deformities, legislation resulted that transformed the safety rules: “The onus shift(ed) to the company to prove the drug should be marketed, rather than to the FDA to prove it shouldn’t.” Now, a post-Vioxx paradigm is emerging, where drug makers are trying to track subtle side effects in enormous populations. The only answer is to set up databases running from the earliest clinical trials through the drug’s launch. “You take something that’s going to evolve over the course of years. You don’t want it forgotten and tucked into a clinical study report that’s forgotten until it emerges as a public policy issue later on and you say, ‘Hmm, curious.’”

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