Side effects and pharmaceutical company bias: adverse event reporting in cancer supportive and palliative care trials.
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.
Jatoi
Aminah
A
Mayo Clinic, Departments of Oncology, 200 First Street SW, Rochester, Minnesota 55905, USA. jatoi.aminah@mayo.edu
Nguyen
Phuong L
PL
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
D000970:Antineoplastic Agents; D004164:Diphosphonates; D004921:Erythropoietin