Prostate Cancer: Fighting the FDA for Your Life

Andrew Schorr:

Welcome back to Patient Power. Hopefully I'm sounding a little better now. We're doing a lot of things behind the scenes to work on our technical connection. I'm way out here in Seattle, and we have people all across the country today. Mike, you're in New Jersey, right?

Mike Kearney

That's correct, Andrew.

Andrew Schorr:

Okay. So, Mike, would you agree with what I said, that this is bigger than an approval or delays in a drug for men with advanced prostate cancer, but it's really issues on what the American public deserves when maybe they're at their sickest stage. It's a more global issue that we've got to fix with the FDA?

Mike Kearney

That is correct. We depend on the FDA, and we have to make sure that they are serving the people, and unfortunately it's been questionable lately, and that's why we're challenging them because we think there are some political issues going on in the FDA. I mean, you've got some different divisions in there that they seem like maybe there's a power struggle, and then there's also some financial conflicts that we're questioning.

When you spoke earlier about testifying, you mentioned that the doctors that they had in there were people that were specialists, and they knew what they were talking about. Unfortunately, two of the most vocal doctors against Dendreon's Provenge, they're oncologists. They are in chemotherapy. They're not in immunotherapy, so there was a little lapse on their part as far as were they really two doctors that should be on the panel, and that's not even to mention the conflict of interest that they did have.

Andrew Schorr:

Well, let's mention something about that. You know, in fairness to the FDA, there are restrictions they work on in putting these panels together where they try very hard to have doctors on the advisory panels who don't have conflicts. Now, what does that mean? That means they don't own stock or maybe don't have a close business relationship with the company applying for approval. Okay, but think about, like in my own condition in leukemia/CLL, it's not a common condition, so any drug company that is developing something is going to want the leading experts in the field to advise them and test their drug, etc. That's the way it works. Well, now we come time to approval, and if you have all the specialists for that illness prevented because of this conflict standard from being on the panel, then the doctors who are on the panel may either not be knowledgeable and/or they may have some other approaches that they believe in that they're financially invested in.

And so, for instance, as you talk about in this prostate cancer vaccine, it's not chemo. So, doctors who make money on infusion of chemo in their office, some oncologists do certainly, they think that this shot you could have would be a good thing, financially maybe not for them. So there are lots of issues behind the scenes.

Now, one of the things I wanted to ask you about, Mike, is there is a government official at the FDA, sort of the head guy when it comes to approvals related to cancer drugs, Dr. Richard Pastor, who is formally from MD Anderson Cancer Center, and I do a lot of work with them. And, he has been kind of a czar there, and he is named in your lawsuit. What do you think is going on with Dr. Pastor?

Mike Kearney

Well, first we think it is part of the political struggle that is going on inside the FDA. We know that some people wanted Dr. Pastor to be the commissioner, now whether this is behind what he is trying to do I'm not sure. We know he was very active at the advisory panel, and we just don't understand if they called the panel and the panel says, listen, this is safe and it shows evidence that it works, even with the dissenting doctors votes, what's the delay?

The other part of the issue is that some people released some information. To us, the FDA should have been keeping everything under wraps while it was considering a decision, but some information went out on the internet. It was made public, and it really brought into question why are these people so anxious to get out there and fight against this, and then as we all started looking at it and uncovering statements for these folks and other competitive drugs that they are working on. And we're going to try to get to the bottom of it.

Andrew Schorr:

Well, that would be good. You know, we've got a question on exactly that. Nick from Portland sent an e-mail, he is listening, and he said, when the FDA overrules an advisory committee panel for treatment of a terminal illness, as in the case of Provenge, shouldn't the FDA be mandated to provided full transparency on why? For starters, which FDA members voted to overrule and their arguments, similar to a Supreme Court ruling, you know, really in detail. And that's what we don't get, so it sort of seems like a hidden agenda, and they just say, more data, more data. And the other thing that I have noticed, and I certainly saw this with Genasense is when you have new kinds of medicines, and in the case of Provenge we are talking about anti-cancer vaccine, and again folks, this isn't a shot you get to prevent you from developing prostate cancer, it's to marshall your immune system to fight the prostate cancer you already have where your immune system had not done that job the first time around. And, so, these cancer vaccines are a whole new approach and so understanding they want to dot their I's and cross their T's but folks like Ted are worried about dying in the meantime, and as you said for your sons Ted, you know, is this going to continue to work this way and deny them maybe the treatment they need.

Ted, let me ask you, have you gone to any congressman or senator yourself or written any letters? Because it's gotta make you angry.

Ted Girgus:

It does indeed, Andrew, and I have indeed. Thanks to the help of the community over the internet that we have, I was able to get the addresses and e-mails of certain congressmen, senators, and even journalists to try to get them involved in the fray, and there has been no response. Our congressmen, they don't even have an automatic e-mail response that says, we're in receipt of your e-mail. I mean, it just goes into this black hole and nothing. So, you know, I wrote to my congressman. I wrote to both senators in the state of Washington, and I e-mailed the FDA just asking for an explanation. You know, and you mentioned earlier, Andrew, you know this isn't just about Provenge and my life. I mean, 30,000 men each year die from this, and die a horrible death by the way, and the only option right now is chemo, and chemo is not effective. And I don't know if people realize, but chemo was derived from mustard gas that they used in World War I. I mean, it's a poison. It's a highly toxic substance, but because of the delay to Provenge and the biotech communities at large, Dendreon had to shelve their Neuvenge, which their phase-1 study against breast cancer; it just came out in the Journal of Clinical Oncology; that it shows positive results, but Dendreon because it was stifled had to shelve their work on Neuvenge. So, it's a snowball that's rolling down hill, and it becomes this giant avalanche unfortunately.

Andrew Schorr:

Right, and as I said, you know, if you're a scientist; let's say that you were the scientist who's working on Neuvenge, and the CEO of Dendreon comes in and says, you know, we just don't have the bucks we can put in this. We're going to continue the fight with Provenge, which is further along, which is great that they can even attempt to do that. Then, you just say, gee, am I in the wrong business? I'm passionate about helping people fight cancer or other illnesses, and yet the roadblocks are just too high, and I'm going to do something else. And that would be a tragedy for our country, and of course these are drugs that are developed for worldwide use, and so it's such a shame.

So, let me go back to Mike. Mike, where are we now? You have a lawsuit. What are you asking for? are you asking approve the drugs or make them available for people in later stage illness like Ted, or allow Eduardo to keep getting it? Where are we with this?

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Page last updated on May 5, 2016