« Science Jobs Roundtable - Day Four |
| Politics in the Lab »
December 17, 2010
The Avastin Decision: A Reality Check
So the FDA did indeed rescind their conditional approval for Avastin in metastatic breast cancer. I think that this was the right thing to do, given that the weight of the evidence now says that it doesn't do any good in that situation. Problem is, there are a lot of people trying to make political points off this decision, saying "See? We told that Obama's health care plan would lead to this. Life-saving medical breakthroughs, pulled because some bureaucrat says that they're too expensive".
Wrong. And I say this as someone who still thinks that the health care plan is a bad idea, poorly implemented. It would be good if other people opposed to it could resist the any-weapon-to-hand temptation in this case, but that's politics for you. (I'd hoped back in August that we could avoid this stuff, but that was always a long shot). The FDA is not in the business of considering costs, just safety and efficacy. And the balance between those two, in the case of hard-to-treat metastatic breast cancer, is not in Avastin's favor. If we're going to speed things up with conditional approvals, we're going to have to be able to take them back when they don't work out. This one didn't.
Here's some good background from WebMD on this decision, and more from Science-Based Medicine on the clinical evidence. That's the evidence we have, and that's why I think this was the right decision.
+ TrackBacks (0) | Category: Cancer | Regulatory Affairs
POST A COMMENT
- RELATED ENTRIES
- Did Pfizer Cut Back Some of Its Best Compounds?
- Don't Optimize Your Plasma Protein Binding
- Fluorinated Fingerprinting
- One of Those Days
- ChemDraw Days
- Incomprehensible Drug Prices? Think Again.
- Proteins Grazing Against Proteins
- Sulfates, And What They Can Make