Coming: Vaccine That Fights Prostate Cancer

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I'm taking a medication that helps to urniate some, my desire is removing it what effect does it have on your body.

Conley Branham of FL 6:17PM December 13, 2009

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Sara of IA 9:16AM December 10, 2009

GrandPa Bunga makes a good point about the timeliness of Provenge compared to Lubaroff's research. People will want what is availble to them at the time. And I think they should get it. At the same time, Lubaroff's promising research should get the forward push it needs.
Until then, and in response to those who object to the cost of Provenge, a cancer therapy of the kind representated by Provenge, and possibly by Lubaroff's, proven in patients, will likely extend its methods to other cancers. That kind of advance will have made the price small.

Derek of WA 10:46PM December 07, 2009

I saw this in U.S. News & World Report, and thought it worth asking a urologist about. I am going to, even though I may not need it.
Let me know if you know anything about it.
I hope you are doing well, even without a "cure".
The urologist I go to has apparently solved my problems related to urination; now for my other problems!
Best wishes,
Harvey

Harvey Ursenbach of AL 9:39PM December 07, 2009

Lubaroff's PSA vaccine must be the best way for dealing with many diferrent cancers.

QIWEI YANG of OH 4:47PM December 07, 2009

This is Hillaryious.
They brain-washed the women, now they are going after the men.
Most men wont buy this fiction of a "vaccine".

Greg of IL 12:48PM December 07, 2009

Finally, what worries me the most about Dr. Vox’s blog is his blind excitement about Dr. Lubaroff’s work. Its great that in a phase I trial the vaccine was shown to be safe, but phase I studies don’t inform effectiveness at all. Prior studies of cancer vaccines in both prostate and kidney cancer were shown to be safe in phase I trials but failed in phase II and III studies (Dr. Vox, look up an agent called Gvax from Cell Genesys- heres a link to help: http://www.medicalnewstoday.com/articles/140746.php) It would be great if Dr. Lubaroff’s approach worked, but to disparage a vaccine (Provenge) that HAS BEEN SHOWN TO WORK in hopes that something better might come along- well, that’s irresponsible and just unfair to men with metastatic hormone-resistant prostate cancer, who have few options right now. Shame on you, Dr. Vox, for turning your back on these desperate patients.

david penson of TN 4:36PM December 05, 2009

I was a site investigator for the IMPACT trial, which is the large phase III study Dr. Vox refers to and was also the individual who presented the results of the trial at national AUA meeting this past April. As such, I’m very familiar with the study and also with the history of Provenge at the FDA. I will state upfront that I OWN NO STOCK IN DENDREON AND HAVE NO FINANCIAL TIES TO THE COMPANY.
I feel the need to respond to some of the inaccuracies of Dr. Vox’s blog and to also call him to task for what I feel is somewhat irresponsible ‘reporting/blogging’ . As Dr. Vox points out, the IMPACT trial (which, by the way, was already well underway in 2007 when Dendreon first submitted their application to the FDA- sorry, while “new goal, new game” sounds sexy- its not what actually occurred) shows a significant improvement in survival in men with hormone-resistant metastatic prostate cancer. Dr. Vox implies that the problem is with clinical significance- that 4 months is not meaningful. However, what he neglects to note is that this study included only men with the terminal form of the disease. Their average survival is 18-20 months, so four months to these men prolongs their survival by 20% on average. I think most rational people would agree that a 20% improvement is clinically meaningful.
Dr. Vox suggests that the FDA should put strong and specific restrictions on Provenge. I think it would be helpful to consider what the FDA does or does not do. The FDA approves a drug for an “indication”. This defines what we call “on label” or “off label” use. If a doctor prescribes a drug for what the FDA says is its indication, then it is on-label. If not, its off-label. The FDA doesn’t encourage or approve off-label use. In fact, if off-label use is UNSAFE, it restricts it. There are many instances, however, of FDA-approved drugs that are commonly and safely used off-label. Dendreon’s application is seeking an indication for hormone-resistant metastatic prostate cancer ONLY. When the FDA approves it (and they will), the only patients it will be indicated for are men with this form of the disease. I’m sure there will be some off-label use but that will be between individual patients and their doctors. Ultimately, the payors will decide if they are willing to pay for off-label use. We should note that, we have no idea what Provenge is going to cost at this point. I have no doubt the price will reflect the manufacturing process required to make the agent, but to speculate on cost-effectiveness now is irresponsible. It is also outside the purview of the FDA’s and CMS’s legislated domains.
Finally, what worries me the most about Dr. Vox’s blog is his blind excitement about Dr. Lubaroff’s work. Its great that in a phase I trial the vaccine was shown to be safe, but phase I studies don’t inform effectiveness at all. Prior studies of cancer vaccines in both prostate and kidney cancer were shown to be safe in phase I trials but failed in phase II and I

David Penson of TN 3:30PM December 05, 2009

The world of oncology research is peppered with good ideas, and the virus approach mentioned here is just another one. It may be good, but there are many other approaches in early preclinical and clinical testing for a variety of malignancies that appear superior in theory, but which when thoroughly tested, simply don't pan out. I also must question the agenda of the writer of this article, since it seems to be saying to delay yet another treatment that demonstrates genuine survival advantage when used alone, and substantial survival advantage when combined with taxol, in the "hopes" that the "theoretical and not-yet-demonstrated" possibility that this virus approach will be better and less expensive.
How nice it would be if we could "divine" in advance which treatment options truly will shake out to be the absolute best ones. But that is not the world we live in: The world we live in with all of its limitations calls us to leave no stone unturned and to incrementally use the best treatment options available as they become available. If a future new treatment for prostate cancer is demonstrated to be superior to Provenge sometime in a near or distant time frame, let it supplant provenge at that time. Until then - and this virus treatment is at best years away from approval- how ethical is it either scientifically or clinically to impede or deny the best demonstrated treatment available to prostate cancer patients? Provenge should be approved immediately, and replace when and if a better option becomes available in the future. In my opinion, divinations have no place in this scientific/clinical discussion; and they certainly don't cut it when dealing with people's lives.
Grandpa Bunga

Grandpa Bunga of IL 11:31AM December 05, 2009

Regardless of price, Provenge is a God send. You can't put a price on life, and four months more with my family is well worth the 50k it may cost, be it out of my pocket or the governments'. Lubraroff's "miracle" vaccine is several years away from even being considered, and that's if it even works. A 32 person trial is hardly something to hang your hat on. If it does turn out to be the Holy Grail of cancer vaccines for the price of a bottle of Aspirin, then wonderful, but the real issue here and now is Provenge. I'm dismayed and angered by thinking of how many lives could have been saved had this drug been approved years ago. The corruption involved with its denial has been well documented, proving that greed is more important than human lives. As a doctor, you should be pressing for Dendreon's success, as it would pave the path for drugs like the one you mention in your article, but to even offer up the question of either or, and potential cost, is ludicrous. I'll take my four months now and gladly pay for it, thank you.
It's they way your article is slanted, Doc, that begs the question: What's your agenda?

May Weiritch of VT 10:58AM December 05, 2009