Prostate Cancer: Fighting the FDA for Your Life

Andrew Schorr:

Right, and I think the other point that I would make, I mean, I know there are concerns. Surrounding all this you have generally senators and congressman get all upset. Is the FDA approving drugs too easily? Whether they're pain medications or for a variety of conditions, and certainly we had some notable ones that were pulled off the market even after they had been on the market for several years. And so, when you take that now to, for instance, the cancer area though, we're talking about life-threatening conditions and where people can't wait, and also I think wouldn't you agree that in the case of prostate cancer, these men with really a late-stage illness would take the risk. They would want to be informed of the risks, and if there are concerns if the FDA says well, we wish we had more data, but still the patients would say, but still make that drug available for me.

Mike Kearney

Yes, I feel like the FDA can paint it how it wants. It granted Dendreon's Provenge fast-track status. It saw enough evidence there that there is something to really look at. So then it called an advisory panel, and Dendreon presented its Provenge, and then the FDA had three folks present what Dendreon had presented to them, and they asked that the advisory council advise them. Well, the 17 people that the FDA picked said 17-0 this drug was safe, and then 13 of them said, it shows substantial evidence that it works. So, we don't understand what the problem is.

Andrew Schorr:

Right. Right. So, I know there's a rally coming up, and you've been involved some, but I saw a rally involving a whole bunch of drugs and different organizations coming up in mid-September at the FDA to try to draw attention to this.

Mike Kearney

That is correct. That rally is going to be on September 18th outside the FDA, and it's, like you said, it is for several drugs, for Provenge for prostate cancer, Genasense for myeloma.

Andrew Schorr:

We're back live on Patient Power, and hopefully you can hear me pretty well. We're doing the program a little differently today, but we have some very important content, and really the idea is should the FDA and its approval process stand in the way of drugs that where scientists are very positive about? But maybe there are still some questions about some, you know, dotting the I's and crossing the T's on some data, but the people with really terminal illness who the scientists and their doctors agree could possibly benefit from those drugs, shouldn't they be available to them?

Let's talk to somebody who is in clinical trial for the prostate cancer vaccine that we're discussing as an example, Provenge. Eduardo Garcia, who is in San Diego. Right, Eduardo?


Page last updated on May 5, 2016