Prostate Cancer: Fighting the FDA for Your Life

Andrew Schorr:

Okay. And you're 64 years old, and you're up the road from me. You're in Bellingham, Washington, on the road to Canada. What's your prostate cancer situation? Have you been, did you, have you had the access to this experimental vaccine in a trial, or was it something you had hoped would be available for you if it were approved?

Ted Girgus:

Well, at this point in time I am on hormones. I am an advanced prostate cancer patient, which means; prostate cancer likes bone, so, it is in my vertebrae and my pelvic region and other areas, and I'm on hormones, and I've been on hormones off and on since I have had my brachytherapy procedure, which unfortunately the cancer was outside the gland by that time.

Andrew Schorr:

Let me just explain that to people. So, there's a procedure done; it was actually developed here in Seattle, and you went to one of the doctors who developed it; where they can implant radioactive seeds in the prostate to try to give radiation directly to where the cancer is, but if the cancer has spread, and it's not always clear whether it has or not, then you need other therapy, and that's what Ted's talking about.

Ted Girgus:

Yes, and then Andrew, and I want people to be aware, to please go in for early detection. My PSA was low. It was 4, and my internist said, well let's move you along for a biopsy. But, you know, even though I had the biopsy and they did notify me that it was cancer, although I went for the procedure, the doctor told me, having cancer is like spilling a jar of salt. You could get all of the granules back in the salt shaker, but if you miss one, you lose. And I think that's part of what happened to me with the brachytherapy.

As a matter of fact, the doctor who performed the brachytherapy, Dr. Haakon Ragde, has since gone to the University of Manila because he was tired of fighting the FDA, and he is using a dendritic cell treatment very similar to Dendreon's, and he is having vast success with it, and anyone who wanted to travel; between the treatment and the travel and the stay, people are looking at $60,000, and it's hard to come up with that. I know your life is on the line, but it's hard for a lot of people to muster that kind of an income just to go for this treatment when we have it right here, you know, in front of us.

Andrew Schorr:

Right. Ted, let me ask you about this. So, here you are with this vaccine to help men with more advanced prostate cancer like you, and your FDA, your tax dollars, a, well thank you very much all you experts in the U.S., and we appreciate your vote, but we're not ready to move forward. How does that make you feel?

Ted Girgus:

You know, Andrew, more than anything, I mean, I'm 64. I have made peace with my god and I lay everything at his feet, but I have four sons, and I have nine grandsons, and the chances of them having prostate cancer because I have it are very high. You know, so, if it's for myself, yes, I would love to live as long as the next person and have a quality of life. One of my heroes is Eduardo Garcia, and I want to grow up to be just like Eduardo when I become an adult.

Andrew Schorr:

Yes.

Ted Girgus:

But again, the FDA, they look at statistics, and if they want statistics, we could give them some. Thirty thousand men die every year. Those are people like Ted and Eduardo, they're not just numbers. It's us, and we die, and our sons die, and our grandsons die. So, if they want statistics, there are some statistics for them. You know, if nothing else, they could have granted a conditional approval on Provenge, which would have allowed us to access it while they were gathering more statistics.

Andrew Schorr:

Now, we have to make another point too, and that is that a lot of the most innovative science in the last few years and certainly in cancer has been from biotech companies, not from big pharmaceutical companies. Not to put down Glaxo or Merck or Pfizer, certainly they do a lot of work, but it's companies like Dendreon or Genta that's been working on Genasense or some of the others, and so when the FDA, these companies raise hundreds of millions of dollars on a bet, you know, with Wall Street and earlier investment, trying to move to the goal line of having a product that they can sell. When the FDA delays approval, even when there's very positive data, it is really a blow to a smaller company like that, and so my concern is it cools off investment, and it also cools off the passion of scientists. They say, why have I been in the lab for all these years and then to have ice water thrown on us?

We're going to take a break in a minute, but I think that is something to think about. Is it not just a delay of Provenge, or as it was a vote against the drug that I thought could help in my condition in CLL, Genasense, but is it really cooling drug development that we all need? Congressmen, senators, anybody might develop a serious illness in the years to come. So, it's a complicated issue, but there is lots to think about. We're going to take a short break, and then we'll be back, and we'll discuss this a lot more and get into it, and of course we welcome your calls on Patient Power as we talk about fighting the FDA for potentially life-lengthening and lifesaving drugs.

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Page last updated on May 5, 2016