How big data’s big bias is bringing noise and conflicts to US drug regulation

Jeanne Lenzer investigates, The BMJ, July 2017

A little known private foundation to support FDA’s “regulatory science” takes money out of the FDA’s coffers to support analyses using levels of evidence recommended by industry; many of the foundation’s directors have financial links to the drug and device makers that the FDA regulates.

Overview
  • No drug risks identified
  • Reagan-Udall Foundation
  • Directors’ ties to industry
  • Panel stacking
  • Funding the foundation
  • Funding the Medical Evidence Development and Surveillance (IMEDS)
  • Light touch FDA

Big data can be used cautiously to examine real world outcomes and to improve surveillance of drug safety. For example, it has been used to identify overuse of some interventions and can show drug and device complications in real world settings rather than idealized controlled trials.

However, big data are a noisy mess, and analyses by entities with profit motives may identify spurious associations that support fast track approvals and indication creep (broadening the indications for drugs and devices).” …

continue reading Jeanne Lenzer investigation Big data’s big bias: bringing noise and conflicts to US drug regulation on The BMJ, 18 July 2017.

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