The Wall Street Journal, and others, have denounced the FDA’s move as “a chillingly blunt assertion of regulatory power.” But my Manhattan Institute colleague Paul Howard is the guy who gets it right, in a blog post for Medical Progress Today:
If you think (as I do) that the FDA should be expanding the accelerated approval pathway and allow more drugs to get to market based on promising early studies. rather than waiting for large Phase III clinical trials that can take years to complete, you can argue that this outcome actually strengthens AA. Critics have charged that AA is sop to industry, and that companies never do the follow up studies to support AA. Avastin proves them wrong.
This is exactly the point. If you want the FDA to approve more innovative, new drugs based on promising but early clinical results, you have to give the FDA a way to revoke those approvals later on, should larger trials prove that those drugs aren’t as safe or effective as they first seemed. This is why the FDA should be congratulated for the way it has handled the Avastin breast cancer saga, and why I hope we will see the FDA handle more cases like this one, not less.
Yes, this is better than the way they’ve done it in the past, but this argument presumes that the FDA should have such regulatory power in the first place. It’s one thing to provide data on efficacy. It’s another to prevent people from making their own decisions about what drugs to use for which ailments.
What’s the chance that I have a bad RJ-45 jack? What’s the QC like on them? The one I’m using is similar to the one described here. I just put in a CAT-5e run, and can’t get it to work (about sixty-five feet). All the wires have continuity, and there don’t appear to be any shorts, but there’s no signal through the cable. Any ideas what the problem might be or how to troubleshoot?
”The results are striking,” said Professor Roberto Bolli, one of the research leaders from the University of Louisville in the US. ”While we do not yet know why the improvement occurs, we have no doubt now that ejection fraction increased and scarring decreased.
”If these results hold up in future studies, I believe this could be the biggest revolution in cardiovascular medicine in my lifetime.”
A total of 23 patients took part in the ”Scipio” trial, all of whom had suffered heart failure due to a previous heart attack. Sixteen were assigned to the stem cell therapy while the other seven received standard care.
Given how dramatic it is, it seems almost unethical to treat the others in any other way.
I’m hoping that I won’t need this, but given my family history, I may. Anyway, I’m glad it’s coming along.