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The evolutionary safety of mutagenic drugs should be assessed before drug approval

Gabriela Lobinska1, Vyacheslav Tretyachenko1, Orna Dahan1

  • 1Department of Molecular Genetics, Weizmann Institute of Science, Rehovot, Israel.

Plos Biology
|March 15, 2024
PubMed

Insights

Certain drugs can accelerate pathogen mutation rates, risking undesirable evolution. A proposed four-step assessment evaluates the evolutionary safety of these treatments before approval.

Area of Science:

  • Microbiology
  • Evolutionary Biology
  • Pharmacology

Background:

  • Some antimicrobial drugs can increase pathogen mutation rates.
  • This mechanism raises concerns about accelerated pathogen evolution toward adverse outcomes.

Purpose of the Study:

  • To propose a framework for assessing the evolutionary safety of drugs that increase pathogen mutation rates.
  • To guide regulatory decisions regarding the approval of such therapeutic agents.

Main Methods:

  • A four-step assessment protocol is outlined.
  • The protocol focuses on evaluating potential evolutionary trajectories of pathogens under drug pressure.

Main Results:

  • The proposed framework provides a structured approach to identify and mitigate risks associated with drug-induced pathogen evolution.
  • This systematic evaluation aims to ensure therapeutic efficacy and prevent the emergence of resistant or harmful pathogen strains.

Conclusions:

  • A robust evolutionary safety assessment is crucial for drugs that elevate pathogen mutation rates.
  • Implementing this four-step evaluation can enhance the responsible development and approval of novel antimicrobial therapies.

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