Todd1963, Water Guy...
The same thought occurred to me. But just to help those on this board who read gillyg's post and had questions, let's discuss some of the issues he raised:
1. He claims (and we have no way of confirming) that he finished his third Provenge infusion on October 12, 2012. Importantly, that was almost 6 months ago from today. Why importantly? Because it takes roughly 6 months for your body's immune system to take up and employ Provenge. As well, if you look at the data from the three pivotal Phase 3 trials that were used to obtain FDA approval, you'll see that the Kaplan-Meier curves didn't begin to separate (that is, begin to show an overall survival (OS) benefit) until Month 6. So, everything else being equal, gillyg's body only now would be moving into high gear in using the Provenge with which he was infused. (I know this over-simplifies the situation, but it's a good, general overview.)
2. Yes, Provenge has no impact on PSA. (There are other ways of controlling that...e.g., with Casodex). And yes, it would be great if there were some objective test to demonstrate that Provenge were working for you. I'm sure that developing and fielding such a test is one of Dendreon's highest priorities. For now, you'll have to put your faith in the statistics derived from the data obtained in three pivotal Phase 3 trials using the treatment.
3. The increase in alkaline phosphotate has been observed in 3% of patients treated with Provenge.
4. Dendreon's manufacturing facility in New Jersey did not close. It was sold to Novartis late last year and 100 of Dendreon's employees were retained to continue the new owner's work in the area of immunotherapy. The facility is an FDA-approved facility that adheres to cGMP practices. If anything, scrutiny of, and adherence to, quality assurance/quality control precedures would have been heightened during the latter part of last year.
5. Yes, Zytiga is a good drug...and yes, it helped to drop your PSA. However, while the pivotal Phase 3 trial that was unblinded last year demonstrated stat sig for progression free survival (PFS), Zytiga did NOT achieve stat sig for overall survival (OS). More to the point, if you look at the unusual Kaplan-Meier curves observed on this trial, they did separate until the 18th month...4 months AFTER patients in the treatment arm came off the drug (by which time 20% of the patients had died). Again...Zytiga showed no OS benefit, which is why it only carries an NCCN Category 2a rating in the pre-chemo space, whereas Provenge carries an NCCN Category 1 rating.
6. You complain about
the price of Provenge (though you never say how much YOU had to lay out). Yet, Zytiga costs $5,400 or so a month, plus prednisone, plus monthly blood tests to check your liver functions. Pre-chemo, in the pivotal Phase 3 trial, Zytiga was administered for 14 months (though 69% of patients in the treatment arm never completed the full 24-month regimen). You're now pushing up close to $80,000 for Zytiga. And remember...Zytiga is reimbursed as a pill...you will go into the donut hole at some point, so in the end, Zytiga may cost you more than Provenge. (More than 70% of all patients who received Provenge had no or little in the way of co-payments. (source: Dendreon Corporation))
7. "In Feb. 2013 My Oncologist informed me that he has had three patients complete Provenge Tx during 2012 and he has not seen any positive results to date." They're alive, aren't they? I would say that's a 'positive.'
8. You raised the issue of Provenge presenting a life-threating situation by delaying your treatment with other drugs. I seriously doubt that was the case. You doctor put you on Zytiga 3 months after your last Provenge infusion...which was 3 months before your body even had fully 'taken up' the Provenge to help you fight the disease.
9. You raise the issue of safety of Provenge. Let's look at the top three adverse effects reported to the FDA for Provenge and then, for Zytiga. Then, you tell me which one presents the greater danger to your health (data from the FDA Adverse Effects database for the period 11/01/1997 to 08/27/2012):
From 11/01/1997 to 08/27/2012, there have been 411 reports of a serious adverse event where PROVENGE was identified as the primary suspect drug causing that event. During that time period, the top three adverse events reported in cases where PROVENGE was identified as the primary suspect drug were: Fatigue, Chills, and Anaemia.
From 11/01/1997 to 08/27/2012, there have been 712 reports of a serious adverse event where ZYTIGA was identified as the primary suspect drug causing that event. During that time period, the top three adverse events reported in cases where ZYTIGA was identified as the primary suspect drug were: Prostatic Specific Antigen Increased, Death, and Fatigue. (I should add here that Zytiga primarily is given to patients post-chemo; pre-chemo, it is given to about
20% of patients who otherwise would be given Provenge. This almost certainly accounts for 'Death' rising near the top of serious adverse events, overall, for the treatment. That said, the treatment is not without its serious side effects, as can be seen by reading the label.)
These are facts. An informed patient is always in a better position to help his physician and himself arrive at the best decision for his own treatment. And while gillyg and others are most certainly entitled to their own opinions, they are NOT entitled to their own facts.
Sun
Post Edited (Sundance2020) : 3/17/2013 9:00:15 AM (GMT-6)