7.10.07 Provenge For Prostate Cancer Revisited, Recent PCA Issues, Prostate Cancer Diet

We’ve dedicated this issue of Prostate Forum to tackling some recent developments in the prostate cancer field—some dietary and others precautionary. Before going on, however, last issue’s piece on Provenge is worth mentioning, as it offered my perspective on a drug that is on the lips of so many people in the prostate cancer community. I think that Provenge is an active agent with a definite, but limited, benefit. In the best of all worlds we now would have this agent available for patient treatment. As you all know, I am a prostate cancer patient and I was personally planning on treating myself with Provenge had it become available. I viewed it as a valuable tool to keep my cancer from returning, so I feel a personal loss now that it is not going to be available. But the most important question to ask at this point is what went wrong with the process in this case. The answer, as far as I am concerned, is that Dendreon made major and obvious mistakes in developing Provenge and not that the FDA is some sort of bad guy. The primary end point of a clinical trial seeking FDA approval should be either survival or improved quality of life. This has been clear for many years, but Dendreon still chose to muddy the waters by changing endpoints midway through the clinical trial. In the end, they forced the FDA’s hand with their poor clinical trial design.

This is actually the second time that we’ve had a useful drug fail in development. The other was atrasantan. Again, it failed not because of the FDA but because of drug company incompetence. This drug was designed to do one thing: block progression of prostate cancer in bone. And yet the company proceeded to include patients without bone metastases in its key clinical trial. So it was hardly a surprise when these patients did not benefit from the drug and the clinical trial did not show a statistically significant benefit. As I write this, I am reminded of the many other situations that have prevented the development of effective agents for prostate cancer. These days, we have enough patients willing to go on clinical trials. I know most of the lead physicians involved in clinical trial testing and I have been very impressed with their professionalism and skill. But I remain stunned by the level of incompetence exhibited by the pharmaceutical industry. This is especially so when you realize that tens to hundreds of millions of dollars are at risk in the process. You would expect the free market economy to do a better job. This comes to the issue of the FDA. It is not an ideal organization by any means and they do some strange things. However, is it really unreasonable for them to ask that drug companies provide proof that a drug works, especially since the path to this proof is so clearly laid out? If we really want to change this, we will need to do it in Congress because right now the law mandates proof of efficacy, effectively binding the hands of the FDA in these matters. But please think carefully about what you would use as a basis for approval if you do not want to use the current criteria. After all, is it really unreasonable to ask for proof that a drug is reasonably safe and either improves survival or quality of life? This seems pretty basic to me and is what I would ask as a patient myself.

Click here to read the rest of the article in volume 10:2 of Prostate Forum.