- About the Lecture
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About the Lecture
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.’”Related Videos
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August 18, 2005
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August 18, 2005
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August 12, 2004
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- About the Speakers
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About the Speakers
Moderator: Isaac S. Kohane
Director, Children's-HST Informatics Program; Associate Director of Bioinformatics, Harvard Partners Center for Genetics and Genomics;
Co-Director of the HST Bioinformatics and Integrative Genomics Training ProgramIsaac Kohane leads multiple collaborations at Harvard Medical School and its hospital affiliates in the application of bioinformatics to an array of multifactorial clinical problems, from tumorigenesis to epidemic outbreaks to autism. Kohane has also led the development of cryptographic health identification systems and automated personal health records.
Isaac Kohane received his M.D. from Boston University School of Medicine. He completed an internship, residency, and fellowship at Children's Hospital Boston.
He is a founder of the Center for Outcomes and Policy Research at the Dana-Farber Cancer Institute, founder and Associate Director for the Center for Genetic Epidemiology at Harvard Medical School. He is a Fellow of the American College of Medical Informatics and of the Society for Pediatric Research.Névine Zariffa
Therapy Area Director, Cardiovascular and Metabolism, Biomedical Data Sciences, GlaxoSmithKline Pharmaceuticals
John Glaser
Vice President and C.I.O., Partners HealthCare
Randall Lutter
Acting Associate Commissioner for Policy and Planning, FDA
Joanna F. Haas
Vice President of Pharmacovigilance, Genzyme Corporation
- About the Host
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About the Host
MIT Center for Biomedical Innovation
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Innovation in Post-Launch Surveillance and Pharmaco-Vigilance
(Part Two)
- Moderator: Isaac S. Kohane
- Névine Zariffa
John Glaser
Randall Lutter
Joanna F. Haas - August 18, 2005
- Running Time: 1:15:01
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