@article{336b218257bb4057bd7d9e23224c72aa,
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. Conclusion: 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.",
keywords = "Adverse events, Cancer, Palliative care, Supportive care",
author = "Aminah Jatoi and Nguyen, {Phuong L.}",
note = "Funding Information: Should more be done to ensure safety, and should more entities be involved? As reviewed above with respect to anti-inflammatory agents and statins, previous studies have suggested marked bias on the part of pharmaceutical companies when reporting clinical trial results. However, should pharmaceutical companies with oversight from the FDA be the only entities responsible for comprehensive and meticulous adverse event reporting? This question becomes particularly relevant in view of the unpublished data we provided above. Although data suggest that, currently, 44% of oncology clinical trials are funded by pharmaceutical companies [21], the majority of cancer clinical trial monetary support (unlike all research in general) nonetheless appears to be derived from non-commercial industries, such as government and foundation support. Such non-commercial entities, as well as practicing healthcare providers who are directly treating cancer patients, must share in the ethical role of reporting adverse events in cancer patients, particularly when it appears that the magnitude of the problem and the extent of longitudinal follow-up are too great for a few groups to take on such responsibility. Indeed, there is published information to suggest that some funding agencies, such as the National Cancer Institute, do not appear to mandate complete and detailed adverse event reporting in the studies it funds. Scharf and Colevas focused on 22 published studies and evaluated the methods for adverse event data reporting outlined in each study protocol [26]. The authors found {\textquoteleft}considerable inconsistency{\textquoteright} in the publication of adverse events, noting that 28% of the high-grade adverse events in the National Cancer Institute{\textquoteright}s Clinical Data Update System could not be matched to what had been published in the study{\textquoteright}s final manuscript and that 27% of published high-grade adverse events also could not be matched to what was seen in the Clinical Data Update System. Although this study focused on only 22 published trials, and although it focused exclusively on trials funded by the National Cancer Institute, it does begin to suggest that there is room for improvement in the thoroughness and accuracy of adverse event reporting in those cancer clinical trials sponsored by the National Cancer Institute. The review and approval of clinical trial protocols do allow funding agencies to have considerable latitude in imposing greater detail and longer follow-up of adverse event reporting – if only such agencies were to mandate it.",
year = "2008",
month = dec,
doi = "10.1517/13543780802513874",
language = "English (US)",
volume = "17",
pages = "1787--1790",
journal = "Expert Opinion on Investigational Drugs",
issn = "1354-3784",
publisher = "Taylor and Francis Ltd.",
number = "12",
}