Sarah Morgan

Healthcare Geek.
Professional Communicator.


On Being Blunt

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 don’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 doesn’t sound like anybody pulled any punches.

From Jacob Goldstein’s blog:

Amgen took a beating yesterday as a panel of outside experts convened by the FDA recommended new restrictions on the use of the company’s blockbuster anemia drug Aranesp in cancer patients. We got a strong sense things weren’t going well when WSJ’s Anna Wilde Mathews filed an item from the hearing that quoted one panel member as asking: “What data do you have to assure me that this is not Miracle-Gro for cancer?”

And then from Anna’s story:

The FDA’s Vinni Juneja, a medical officer, offered some veiled – and not-so-veiled – criticism of several studies of the medicines. One of the slides in his presentation asked whether “any ongoing or proposed trials” presented to the same committee in 2004, or since, fully met that panel’s earlier recommendations. The answer, in a giant font, was: “NO.”

Love it.


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