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What Can We Do to Make Progress?

Program: Prostate Cancer: Fighting the FDA for your Life
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Andrew Schorr:

Yes, I was saying, what do you think we need to do to move this mountain? Because it seems daunting. You feel like you can't fight city hall. We've talked about how the FDA is not transparent to somebody. One of our listeners said we wish they would explain all their reasoning. How do we move this mountain?

Mike Kearney

Okay. First of all, we encourage as many people as possible to go to the rally on September 18th at the FDA. You can access this information on caretolive.com. There is another web site call arighttolive.com. We believe we can prove all the assertions that we made in our pending case against the FDA. And so we're going to pursue that, and we are going to challenge them, and we also would like to ask Congress to get involved and look at making some changes at the FDA even with policy. Even two of the doctors that were so vehemently against Provenge, one of them was quoted not too long ago saying even the slight benefits are significant in a tough disease. Well, this is a tough disease. And then the other doctor said it may be time we focus less on statistical significance alone and more on patient benefit. So, if these doctors believe this, and then they see the safely of Provenge, what's the problem?

But to answer your question, Andrew, we are going to keep pursing it. We're pursuing the lawsuit, and we're pursuing to see if we can get some changes inside the FDA to help the American people. I mean, a lot of this stuff is so common sense. I explained it to a third grader. I said, look, here's what happened, and you explain what immunotherapy does, and they get it. We just don't know why the FDA didn't get it.

Andrew Schorr:

Right. Well, I want to help you, and again just a word about immunotherapy if people are not up on it. And the idea was, is that your immune system did not recognize these defective cells that your own body was creating. That's what cancer is. And so, the idea is to convince your immune system that it can do better and help it do that, and that's the whole idea of cancer vaccines where otherwise chemotherapy is typically just looking for cells that are dividing and not dying and just kind of wipe them out, and it causes the collateral damage we talked about; hair loss and nausea and fatigue, etc. And so, that's why these targeted immunotherapies are so promising, but there have been a lot of road blocks to so many of them and certainly from some of the smaller biotech companies. Not always, but here's an example, and it's very frustrating.

We did get a comment in from Steven who wrote, guess what Ted? He wrote, we're on our way to Manila since my dad can't get Provenge here in the states. And as he says, it's just so sad. So Ted, there's a guy who knows whether they are wealthy or not using what dollars they have to go to where I guess Dr. Ragde is now to get what they believe has promise but can't be approved by our own government. So, pretty frustrating.

Let me mention these web sites again. So, there is caretolive.com, and that's the one founded by Mike, and then there is also arighttolive.com, and they've been organizing this rally. This rally we've been talking about is September 18th from 10:00 a.m. to 12:00 noon Eastern time right there at the FDA, 5600 Fishers Lane, Rockville, Maryland, and the idea is to get cancer survivors and family members there, parade around so the FDA sees, but most importantly bring the attention of the press.

Now, I wanted to ask Mike one question. You know, we get approached a lot of times by public relations people, and there are some very good ones, but usually they are representing some commercial interest trying to advance sales for that product, medical product, whatever. Sure, if Provenge was approved, that would help Dendreon and its investors a lot. But that's not what we're talking about, and what I get from you Mike, and Ted and Eduardo, is it's just us patients trying to have our government do what's right. Would you agree?

Mike Kearney

Absolutely Andrew. That's absolutely what we're hoping for. It's time to turn a page in cancer treatment. Immunotherapy is the new thing, and Provenge is demonstrated to be safe in more than six clinical trials, the most common complaint was two-four days of flu-like symptoms, like Eduardo told us, and the people are living four and a half months longer on average than the current treatment of Taxotere, which is the chemotherapy, and sometimes we're amazed that the chemotherapies ever got approved because if we can't get immunotherapy, which is safer and a better immune system instead of a chemotherapy, which is also destroying the good cells, we just say, wow, what's going on here? So, it's just basic common sense.

Andrew Schorr:

I do a lot in cancer, so I just want to mention and I want to be fair to chemotherapy too.

Mike Kearney

Sure, sure.

Andrew Schorr:

So, I benefited from a monoclonal antibody, an immunotherapy in a way, being combined with chemotherapy. And many of the cancer doctors think at least for the next little while, there will be these sorts of combinations.

Mike Kearney

Right. We've seen a cycle where Provenge was given and Taxotere and then a Provenge booster, and we've seen better results with that. But we got Taxotere out there; let's get Provenge out there now so we can do these kinds of treatments where they are showing good results.

Andrew Schorr:

Right, right. Well, I wish you well with the rally. Unfortunately, it may take a senator or a senator's spouse or somebody like that to find themselves in the same boat that Ted's in to say, hey, what's going on, and for them to be chairman of some committee that approves the budget for the FDA. I'm not sure, you know, I wish you well with your lawsuit, and I hope it goes well.

We'll discuss this more, and I hope you will keep us updated on the progress, but I urge people to go to the caretolive.com web site, and if you can, if you're anywhere near Washington D.C. and you're affected by all this, you know, just like we've had other marches on Washington, have a march on the FDA September 18th, 10:00 a.m. to 12:00 noon right where the FDA office are at 5600 Fishers Lane, Rockville, Maryland, right outside Washington D.C.

Oh boy. Well, I think we can make a difference. Mike, I want to give you a lot of credit for what you're doing and just really wish you all the best. Ted, do you think this can make a difference?

Ted Girgus:

You know what? We need to learn from what the HIV people did. We need to make some noise. We do not want to go quietly into that good night, Andrew. So we just need to make some noise and get people's attention because we've got something worth hollering about.

Andrew Schorr:

Right. We sure do. Best to all of you. As always, knowledge can be the best medicine of all. Good luck guys.

Ted Girgus, Mike Kearney, Eduardo Garcia:

Thank you Andrew. Thank you for all you do. Thank you Andrew.

Andrew Schorr:

Thank you. Thanks gentleman.

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