I don’t usually talk about work sorts of things here but this is pretty great.
Well. As great as an FDA oncology advisory committee can be. (Provided you donâ€™t own Amgen stock.)
But it’s great when people just come out and say what they think. Especially when it’s about something important.
The FDA had an advisory committee meeting to talk about two drugs that are supposed to help cancer patients deal with chemotherapy-related anemia. They’re trying to figure out whether they help, or whether they can actually make things worse. And it doesnâ€™t sound like anybody pulled any punches.
Amgen took a beating yesterday as a panel of outside experts convened by the FDA recommended new restrictions on the use of the companyâ€™s blockbuster anemia drug Aranesp in cancer patients. We got a strong sense things werenâ€™t going well when WSJâ€™s Anna Wilde Mathews filed an item from the hearing that quoted one panel member as asking: â€œWhat data do you have to assure me that this is not Miracle-Gro for cancer?â€
And then from Annaâ€™s story:
The FDAâ€™s Vinni Juneja, a medical officer, offered some veiled â€“ and not-so-veiled â€“ criticism of several studies of the medicines. One of the slides in his presentation asked whether â€œany ongoing or proposed trialsâ€ presented to the same committee in 2004, or since, fully met that panelâ€™s earlier recommendations. The answer, in a giant font, was: â€œNO.â€
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