Side effects and pharmaceutical company bias: adverse event reporting in cancer supportive and palliative care trials

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.

The purpose of this opinion piece is to reexamine what happened.

We relied on the published literature as well as the investigators' own experience and preliminary data.

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.