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[The need for 'postmarketing surveillance'].

B H Stricker1, B A in 't Veld, J Feenstra

  • 1Erasmus Universiteit, afd. Epidemiologie & Biostatistiek en Interne Geneeskunde, Rotterdam.

Nederlands Tijdschrift Voor Geneeskunde
|May 29, 1999
PubMed
Summary

Postmarketing surveillance is crucial but underutilized. Pharmaceutical

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Area of Science:

  • Pharmacovigilance and pharmaco-epidemiology are key components of postmarketing surveillance.
  • This study highlights the limited execution of essential postmarketing surveillance activities.

Context:

  • Postmarketing surveillance is vital for drug safety and efficacy monitoring.
  • Current pharmaceutical industry practices, such as 'seeding trials,' undermine genuine postmarketing surveillance.
  • These trials offer financial incentives to physicians, influencing prescribing habits with scientifically invalid results.

Purpose:

  • To critically evaluate the current state of postmarketing surveillance for medicines.
  • To contrast scientifically rigorous surveillance with industry-sponsored 'seeding trials.'
  • To assess the potential for genuine postmarketing surveillance through collaborative studies.

Summary:

  • Postmarketing surveillance, encompassing pharmacovigilance and pharmaco-epidemiology, is insufficiently conducted.
  • Pharmaceutical industry 'seeding trials' are scientifically worthless and compromise authentic surveillance efforts.
  • A Dutch study on ibopamine mortality showed healthcare professionals' willingness to participate in adverse reaction research.

Impact:

  • Highlights the need for more scientifically sound postmarketing surveillance studies.
  • Underscores the detrimental effect of industry-biased trials on drug safety monitoring.
  • Demonstrates the feasibility and importance of collaborative research in pharmacovigilance.

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