title: Side effects and pharmaceutical company bias: adverse event reporting in cancer supportive and palliative care trials.
abstract: BACKGROUND
  Over 10 years after their approval as cancer supportive and palliative care agents, erythropoietin and the bisphosphonates began to show unexpected, serious adverse events, which resulted in dramatic changes in how they were subsequently prescribed to cancer patients.
  
  
  OBJECTIVE
  The purpose of this opinion piece is to reexamine what happened.
  
  
  METHODS
  We relied on the published literature as well as the investigators' own experience and preliminary data.
  
  
  CONCLUSIONS
  The importance of adverse event reporting in cancer supportive and palliative agents should go beyond that which is mandated by the Food and Drug Administration (FDA). Funding agencies and practicing oncologists should remain vigilant for such adverse events during the testing of new agents and after their approval. They should be willing to report such events without delay.
authors.affiliation: Mayo Clinic, Departments of Oncology, 200 First Street SW, Rochester, Minnesota 55905, USA. jatoi.aminah@mayo.edu
authors.forename: Aminah
authors.initials: A
authors.lastname: Jatoi
authors.forename: Phuong L
authors.initials: PL
authors.lastname: Nguyen
mesh_terms: D000970:Antineoplastic Agents / Q000009:adverse effects* / Q000627:therapeutic use*; D004164:Diphosphonates / Q000627:therapeutic use; D004921:Erythropoietin / Q000627:therapeutic use; D006801:Humans; D009369:Neoplasms / Q000188:drug therapy*; D010166:Palliative Care
chemical_list: D000970:Antineoplastic Agents; D004164:Diphosphonates; D004921:Erythropoietin