4 Topic Commentaries

Side Effects: Context Is the Diagnosis

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  Gerald J. Dal Pan, MD, MHS

  Pharmacovigilance and epidemiology

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  U.S. Food and Drug Administration, Center for Drug Evaluation and Research (CDER)

  Because the reports in FAERS are reports of adverse events, one cannot assume that these events were caused by a drug.

  Source
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  Luana Colloca, MD, PhD

  Bioethics and placebo/nocebo research

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  National Institutes of Health (NIH)

  Nocebo effects are adverse events produced by negative expectations and represent the negative side of placebo effects.

  Source
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  Ulrike Bingel, MD, PhD

  Neurology

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  University Hospital Essen, University of Duisburg–Essen

  Converging evidence suggests that the occurrence of unwanted adverse events during drug treatment is in part determined by nonpharmacological effects.

  Source
• 

  Peter Marks, MD, PhD

  Biologics regulation and vaccine safety

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  U.S. Food and Drug Administration

  What VAERS doesn’t do, though, is tell us whether a vaccine caused a medical issue. That requires investigation.

  Source