ASCO Poster: Reporting Adverse Drug Events Has Chilling Effect

Ashley Godwin


June 02, 2019

Hi, I'm Ashley Godwin, a PhD student at the College of Pharmacy, at the University of South Carolina. I'm here at ASCO to talk about my research interviewing clinicians about their experiences after publishing a near-fatal adverse drug reaction in the oncology realm.

We found clinicians who not only had reported to the US Food and Drug Administration (FDA) but actually published on adverse drug reactions, and these were very serious: VTE, hemorrhage, brain infection, new tumor progression, etc. They collected cases and chose to publish them in the medical literature.

This is really interesting. because only about 1% to 10% of all adverse drug reactions are ever reported to the FDA. So the fact that these clinicians chose to publish in the literature really shows their commitment to getting the info out there.

We talked to them about their motivations for reporting and about their experiences with the academic community where they worked, the FDA, and also the pharmaceutical companies.

Across the board, most people had positive experiences with their academic institution. They got a pat on the back and their academic community said, "We support you no matter what."

With Pharma, however, most experiences were negative. Some people had great experiences and were even put on safety committees, but some had negative experiences. For example, one person said that they were threatened with being sued for defamation after the report came out.

With the FDA there were some positive experiences and some negative as well. One person said that he kept submitting reports to the FDA and didn't hear anything back. Another person said that the FDA decided to work with another clinician after that.

I think it's really important to be aware of this issue. These clinicians are doing a great job publishing about adverse drug reactions. But when we asked them, would you publish again? A lot of them said, "No," because they had gone through so much.

So, we are very thankful for the clinicians who do report adverse drug reactions. It's very important, especially with these serious reactions. We just wanted to make everyone aware of this dynamic issue.

Thank you.

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