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Author: missash Big gold star, 5000 posts Old School Fool Add to my Favorite Fools Ignore this person (you won't see their posts anymore) Number: of 70966  
Subject: What is to be gained........? Date: 4/26/2007 1:21 PM
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Just musing; thinking about just what is to be gained by the use of Provenge in hormone resistant prostate ca.......my knowledge is limited, so correct me if I'm wrong, but from my perspective what is gained is a few months of additional life. What is that life like? Its "quality"? If the metastases are causing pain, is the pain relieved? Is the anorexia and weakness so common in end stage patients affected positively? I've seen nothing describing the quality of that additional life. Is it worth the cost and effort on the patient's part to make treatment worthwhile. There is another choice in addition to chemotherapy and/or Provenge, and that's supportive care(think Hospice). In other words, I think what I am asking is "are the extra few months bought at the expense of additional misery." If so, I guess I just don't "get it".
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Author: levi2 Three stars, 500 posts Old School Fool Add to my Favorite Fools Ignore this person (you won't see their posts anymore) Number: 30750 of 70966
Subject: Re: What is to be gained........? Date: 4/26/2007 1:34 PM
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Supposedly, hopefully, the immune system being "boosted" by Provenge, will cause a remission in the cancer & patients will actually feel better & live much longer than the two or three months reported. Just read about such a case over on the DNDN board within the last two days or so.............

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Author: captainccs Big funky green star, 20000 posts Top Favorite Fools Old School Fool Add to my Favorite Fools Ignore this person (you won't see their posts anymore) Number: 30752 of 70966
Subject: Re: What is to be gained........? Date: 4/26/2007 1:48 PM
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missash, that is an excellent question. Terminal cancer is absolute misery. From my very limited experience with it, I have found that group therapy is one of the best palliatives in that it brings peace of mind to the patient and to his family and friends.

One BIG problem I have discovered with doctors is that they focus on illness and not on quality of life. Dr. William Thomas emphasizes the importance of "A Life Worth Living." I can see no good in prolonging a life that is not worth living, neither for the patient nor for his family. This is were the group therapy is so wonderful in that it brings peace of mind.

Denny Schlesinger


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Author: 11x Big red star, 1000 posts Old School Fool Add to my Favorite Fools Ignore this person (you won't see their posts anymore) Number: 30754 of 70966
Subject: Re: What is to be gained........? Date: 4/26/2007 1:54 PM
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Why are you so down on Provenge? All of your posts are negative. Is DNDN not focused on fighting cancer? Have you read the results of patients using Provenge+Taxotere+Chemo? Even Provenge alone the results are impressive. You responded to this thread so you have seen the results.

http://boards.fool.com/Message.asp?mid=25424852

I don't know if your opinion is a more philisophical question that each one must answer themselves, but I guarantee you given the chance of overcoming Prostate Cancer, many would opt to fight it any means necessary.

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Author: missash Big gold star, 5000 posts Old School Fool Add to my Favorite Fools Ignore this person (you won't see their posts anymore) Number: 30757 of 70966
Subject: Re: What is to be gained........? Date: 4/26/2007 2:12 PM
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<<<<<<<Why are you so down on Provenge>>>>>>>. I just don't think it is all that many/most here seem to think it is.

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Author: missash Big gold star, 5000 posts Old School Fool Add to my Favorite Fools Ignore this person (you won't see their posts anymore) Number: 30759 of 70966
Subject: Re: What is to be gained........? Date: 4/26/2007 2:20 PM
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<<<<<<<I don't know if your opinion is a more philisophical question that each one must answer themselves>>>>>>> Yes, after many years in the "trenches" practicing oncology I suppose I have adopted a philosophy; sort of like "you have to know when to hold them and know when to fold them"........some situations you can influence positively in a meaningful way; other situations you are best off doing "nothing"......adding 4 months of misery in metastatic prostate ca. falls into the latter category, imho.

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Author: cheung62 One star, 50 posts Old School Fool Add to my Favorite Fools Ignore this person (you won't see their posts anymore) Number: 30762 of 70966
Subject: Re: What is to be gained........? Date: 4/26/2007 2:27 PM
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What is to be lost...?

I'm sorry, but as Joe Average here, I would say if side effects are negligible, this drug should be available to those afflicted. After reading Rackled's a/c of chemo, that to me describes nothing to be gained from Taxotere, which is an approved drug.

There are no guarantees, even with drugs that meet the arbitrary, mythical .05 statistical marker.

So, I ask you again: What is to be lost? What is so important that there needs to be such a huge fight over approval? Except money; not you missash, but the forces that seemingly are so intractably against approval, or any version thereof.

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Author: mauser96 Big gold star, 5000 posts Old School Fool Add to my Favorite Fools Ignore this person (you won't see their posts anymore) Number: 30763 of 70966
Subject: Re: What is to be gained........? Date: 4/26/2007 2:32 PM
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"adding 4 months of misery in metastatic prostate ca. falls into the latter category, imho. " That's the mean , 4.5 months, and there are quite a few people now living way beyond that with few symptoms.That's not my opinion, it's the opinion of patients like Mr Garcia who spoke at the AC meeting. Then there's that 14 month mean survival when used with tax. Certainly it's worth taking the Provenge,since it helps symptoms for a while and has no downside. A cure would be nice, but we don't have that yet, so patients should be offered a choice. Some might choose nothing, but that should be their choice, not the choice of a paternalistic FDA or urologist.


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Author: twopairfullhouse Big gold star, 5000 posts Top Recommended Fools Old School Fool Add to my Favorite Fools Ignore this person (you won't see their posts anymore) Number: 30764 of 70966
Subject: Re: What is to be gained........? Date: 4/26/2007 2:37 PM
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I think what missash is alluding to is whether or not it's worth approving, if most are going to have negligible improvement in lifespan and/or quality of life. If the results are not spectacular, are we as a society willing to pay the large amounts necessary for the treatment? I say, 'we as a society', because we're all paying into Medicare. Are the treatments going to be worth the money? I think it's a valid question from someone who has been in the trenches.

However, I don't think the FDA should be doing too much along the lines of whether a particular drug is worth what the provider is charging. Their inquiry should be mainly confined to whether it is safe. Efficacy is what Scher and Hussain seem to be hung up on. If they're being honest here, I have no problem with their objection.

Dean

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Author: cheung62 One star, 50 posts Old School Fool Add to my Favorite Fools Ignore this person (you won't see their posts anymore) Number: 30765 of 70966
Subject: Re: What is to be gained........? Date: 4/26/2007 2:41 PM
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Don't you need to look beyond Provenge as well? More trials would be nice in theory, but even that is not proof it works. Only general use over time can prove that. (correct me if I'm naive about the science here) Meanwhile, you have a drug, which if shown to work, can potentially open up a vast, whole new arena to combat cancer. The upside to that scenario is the real question here, not Provenge; again, from my Joe Average perspective.

What I see are oncologists defending their "turf", if you will. And that aspect, I do know about.

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Author: captainccs Big funky green star, 20000 posts Top Favorite Fools Old School Fool Add to my Favorite Fools Ignore this person (you won't see their posts anymore) Number: 30767 of 70966
Subject: Re: What is to be gained........? Date: 4/26/2007 2:45 PM
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I say, 'we as a society', because we're all paying into Medicare.

twopairfullhouse


And that justifies denying a safe drug to someone who is willing and able to pay?

Denny Schlesinger

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Author: TMFBreakerTinker Big gold star, 5000 posts Old School Fool Add to my Favorite Fools Ignore this person (you won't see their posts anymore) Number: 30768 of 70966
Subject: Re: What is to be gained........? Date: 4/26/2007 3:03 PM
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Wait a minute here, should Provenge be approved?

The median survival from taxotere is 2-3 months with so many side effects and detriment to quality of life that the majority of men choose not to take it. THIS IS THE APPROVED GOLD STANDARD OF TREATMENT.

Provenge shows substantial evidence of efficacy. If the evidence holds up here is what you have (1) 4.5 months median survival advantage, and 34% of patients living more than 3 years vs. 11% on placebo with a log ranked p valued of .0001 or was it .001.

Yes the study was 128 patients, but each and every angle was checked to determine the veracity of these results. The only thing against the results, which measured 100% of the population, not a subset, was that it was the secondary endpoint. There exists some selection bias in the data I suppose, but for crying out loud, are you dead or are you alive? The rest of the selection was ignored.

Oh yes, and no material side effects. Between Provenge and Taxotere, which drug do you choose.

But wait, wait, when Provenge is used prior to Taxotere the survival benefit of 2-3 months is now extended 14+ plus months so as to make the hardships of taxotere possibly worthwhile.

Nah, it is not a cure. Just an improvement in treatment, and an improvement in quality of life. Therefore not worthy of moving forward. Not something we as a nation should make available for our male population to choose to use when there is nothing else available.

Sorry, the logic does not fly. Neither does it fly on a humanitarian basis. There is clear and substantial evidence of efficacy. There is a desperate unmet need. And it is clearly an improvement. No, we cannot say with certain how well it works, but it is very probable it does work. And even if its efficacy is 1/2 that of 9901, that is the same efficacy of taxotere, only without the side effect. ERGO, an improvement in treatment and quality of life.

Sorry, again. You were saying we should just keep the status quo? And btw/ set back research and R&D in this area of cancer research. The only area of cancer research presently showing any promise of improving cancer treatment as chemotherapy has pretty much reached its apex.

I'm just not there, sorry again.

missash, I understant the data issues. We can debate those forever, but it is without doubt they do not meet the standards of traditional cancer drug approval. But outside of that, I cannot understand why a drug that is better than what exists should not be approved.

Tinker

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Author: missash Big gold star, 5000 posts Old School Fool Add to my Favorite Fools Ignore this person (you won't see their posts anymore) Number: 30770 of 70966
Subject: Re: What is to be gained........? Date: 4/26/2007 3:10 PM
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<<<<< Just an improvement in treatment, and an improvement in quality of life>>>>>> Tinker, what is the evidence that it improves the "quality of life"? Has performance status even been addressed? ( Karnofsky score or the like). I am not suggesting it should not be approved. I just don't think it is the major advance many here seem to think it is.

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Author: TMFBreakerTinker Big gold star, 5000 posts Old School Fool Add to my Favorite Fools Ignore this person (you won't see their posts anymore) Number: 30771 of 70966
Subject: Re: What is to be gained........? Date: 4/26/2007 3:18 PM
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The improvement in quality of life is in comparison to using taxotere or in comparison to using nothing at all.

As to the amount of improvement in quality of life that has still to be fully explored. As admittedly the trial data is minimal from what we would like to have.

But for those 34% of patients vs. 11% placebo, p value no greater than .001, and could be .0001, those patients have not been living in pain, in hospices, under massive doses of opiate pain killers. They have been out living their lives.

Within that survival number is implicit and drastic improvement in quality of life vs. what taxotere alone offers and what doing nothing alone offers.

What remains to be seen is how well it works, for whom it works, and how it works best. As with any medication, not all patients will take to it, but the data indicates that those who do take to it some amazing things have resulted.

Will it be all we can hope it will be? I don't know. I am on the record as stating we can't really know if 9901 was a false positive or not, other than when you look at the data in depth, there are a lot of supporting evidence that indicates it is not just a false positive. Even when looking at 9902A you can see it through the data. It just does not appear to be a typical false positive.

But the real decision is whether or not the United States is better or worse off by offering this option to this indication of patients, at this time and the answer as I mathematically laid if out a few weeks ago comes down to the following:

.95 xcost of withholding for 3 years if drug indeed works as substantia evidence indicates <> .05 x cost of drug not working despite substantial evidence that it does but okaying now.

Or something like that, I'll hae to go back and check the equation. But it was utterly and overwhelming in favor of present approval.

Whether it turns out to be like penicillin or not in the end, this much I do know. It is highly probable that it is better than the existing gold standard in this indication for most patients.

Tinker

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Author: missash Big gold star, 5000 posts Old School Fool Add to my Favorite Fools Ignore this person (you won't see their posts anymore) Number: 30772 of 70966
Subject: Re: What is to be gained........? Date: 4/26/2007 3:22 PM
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. <<<<<It is highly probable that it is better than the existing gold standard in this indication for most patients.>>>> Jeez, I wish you would use a different standard. The present one "stinks'.


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Author: TMFBreakerTinker Big gold star, 5000 posts Old School Fool Add to my Favorite Fools Ignore this person (you won't see their posts anymore) Number: 30774 of 70966
Subject: Re: What is to be gained........? Date: 4/26/2007 3:26 PM
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I know it. My father in law passed away at age 65. He refused to except the existing gold standard. My brother in law knows it is in his jeans and is already being checked annually in his early 40s. Scary despite all out technology the prostate and the breast can be so problematic. Not as bad as the pancreas mind you. Lots of promise in non-conventinal BLAs and immunotherapy treatments. Even chemoresensitizers such as with ovarian cancer. But I think it is going to take a Provenge like mechanism to get us to the promised land here long-term.

Tinker

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Author: TMFBreakerTinker Big gold star, 5000 posts Old School Fool Add to my Favorite Fools Ignore this person (you won't see their posts anymore) Number: 30776 of 70966
Subject: Re: What is to be gained........? Date: 4/26/2007 3:34 PM
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Make that in his genes, not jeans;) I just type and think too fast sometimes.

Tinker

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Author: karmaoption One star, 50 posts Old School Fool Add to my Favorite Fools Ignore this person (you won't see their posts anymore) Number: 30780 of 70966
Subject: Re: What is to be gained........? Date: 4/26/2007 3:56 PM
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What is to be gained from a few months in life. I can't comment on myself, but I will comment on my brother. He died from Aids back in 1989 when they had very few treatment options, actually one as I remember, AZT. My brother was as full of life as anybody I knew, and it took about 2 years from diagnosis to death. Now what my brother actually died from was Kaposi's Sarcoma in the lungs, so the proximate cause of his death was lung cancer. Two months before Tom died, he had radiation to combat the kaposi's throughout his body. The radiation severely burned his legs, 2nd degree burns. What did he do 3 days later, he went Parasailing even though his legs were useless. He said he would be landing on the water, or sand at worst so he did not care, he wanted to live while he had time. My brother died going to Oregon to visit friends from College that he wanted to make sure he saw for one last time. Oregon has alot of very mountainous area, and he went to Eugene. Most of the areas he went to was above 5,000 feet. He had no lungs basically and was on pure oxygen, so he knew it was going to kill him when he went, but he wanted to spend the extra time to see those that mattered. Once again extra time. He died in Eugene on a respirator, because the altitude had put him into respitory failure. He waited until we made it to Eugene, so we could be at his bedside when he died. He made the decision to turn off the respirator himself, and it was the most courageous thing I have ever seen anyone do.
Please don't tell me that 4-5 months extra is not important if you are in terrible pain unless you are that person. I know for a fact that one person regardless of how terrible things were, wanted to use the time he had to live to the fullest, do things he never did, and see those he loved. He would have loved another 4-5 months, and would have made the most of it, regardless of how he felt. Sorry but it touches a hot button for me!!

John

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Author: TMFBreakerTinker Big gold star, 5000 posts Old School Fool Add to my Favorite Fools Ignore this person (you won't see their posts anymore) Number: 30783 of 70966
Subject: Re: What is to be gained........? Date: 4/26/2007 4:08 PM
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I will tell you this, if my father in law had an extra 4-5 months he would have seen his twin grand babies. An extra 2-3 years he would have played extensively with his twin grand babies.

For the 34% of men living 3+ years vs. 11% placebo (and this includes crossovers), that is 34 out of every 100 vs. 11 out of every 100. False positive? Maybe. Most probably not, but the chance still exists.

Tinker

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Author: rackled Big red star, 1000 posts Old School Fool Add to my Favorite Fools Ignore this person (you won't see their posts anymore) Number: 30790 of 70966
Subject: Re: What is to be gained........? Date: 4/26/2007 4:35 PM
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I can tell you one thing for sure: Missash didn't practice any oncology as she suggested in her previous post. Someone that practiced oncology would know very well what the statistics for Provenge mean because these are the kind of benefits that characterize all of oncology. So very low...


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Author: rackled Big red star, 1000 posts Old School Fool Add to my Favorite Fools Ignore this person (you won't see their posts anymore) Number: 30791 of 70966
Subject: Re: What is to be gained........? Date: 4/26/2007 4:38 PM
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*Sticks foot in mouth*

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Author: WeekendHack Three stars, 500 posts Old School Fool Add to my Favorite Fools Ignore this person (you won't see their posts anymore) Number: 30793 of 70966
Subject: Re: What is to be gained........? Date: 4/26/2007 4:54 PM
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You never really know unless it touches you. Sometimes we just have no clue that we have no clue. Thanks John.

WeekendHack

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Author: missash Big gold star, 5000 posts Old School Fool Add to my Favorite Fools Ignore this person (you won't see their posts anymore) Number: 30796 of 70966
Subject: Re: What is to be gained........? Date: 4/26/2007 5:07 PM
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<<<<<<I can tell you one thing for sure: Missash didn't practice any oncology as she suggested in her previous post. Someone that practiced oncology would know very well what the statistics for Provenge mean because these are the kind of benefits that characterize all of oncology. So very low...>>>>> atta boy, rackled, when you have nothing sensible or worthwhile to say, attack the messenger. Ever heard of MOPP or ABVD to treat Hodgkin's Disease, or a number of combination chemotherapies to treat Acute Lymphocytic Leukemia or Acute Myelocytic Leukemia, or Glevac to treat CML....low benefit? Your inane comments are laughable


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Author: dumaflotchie Big gold star, 5000 posts Old School Fool Add to my Favorite Fools Ignore this person (you won't see their posts anymore) Number: 30797 of 70966
Subject: Re: What is to be gained........? Date: 4/26/2007 5:42 PM
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Your inane comments are laughable

Hey Missash:

You really needn't feel compelled to respond to Rackled......he is not a doctor but did stay at a Holiday Inn Select ;)

Your questions and questioning are appropriate especially for doctors who merely seek the truth. This board is highly motivated by the financial risk and many are highly leveraged. So there can be a little "acting out" because there is a lot on the line for many.

As to the 3-4 months improved survival, I think at first blush your concerns are justified but if you did a little further, it is of interest that taxotere has/had similar efficacy. I find the more compelling argument to be combined therapy and not standalone. The combination had survival benefit that was impressive and for essentially minimal additonal risk.

The biggest problem that many here choke on is that this survival benefit was not a primary endpoint of the study. As you well know, that study design flaw could result in greater possibility of chance due to unequal populations, etc.

But recognizing this flaw, it may still be effective as combined therapy and the earlier the better. In a perfect world, we would know the "b" results......that would be the most compelling.....but by then the stock as popped and gains will have to be earned the old fashion way (see ELN).

The interesting aspect of this whole argument is that neither side can really be definitive because we do not know "b". But despite that uncertainty (a fact), people argue as though it is gospel.

Forget the arguments and simply put your nickle down.......no one can know the answer until "b" is out and along the way there can be some nasty or glorious bumps (such as 5/15). This is really shaping up for a big swing in some direction with FDA decision shortly.




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Author: missash Big gold star, 5000 posts Old School Fool Add to my Favorite Fools Ignore this person (you won't see their posts anymore) Number: 30799 of 70966
Subject: Re: What is to be gained........? Date: 4/26/2007 5:50 PM
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Thanks, Duma, for what I consider a thoughtful, balanced message. Others can choose to believe what they wish, but I have no investment in DNDN.....just interested in the science and proof of it.

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Author: rackled Big red star, 1000 posts Old School Fool Add to my Favorite Fools Ignore this person (you won't see their posts anymore) Number: 30800 of 70966
Subject: Re: What is to be gained........? Date: 4/26/2007 6:07 PM
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My inane comments happen to be correct. I find it funny you claimed expertise about urologists and were later rebuked by a urologist himself who happened to verify what I was saying. How can you claim knowledge and then subsequently claim ignorance?

Wow, great examples. There are a ton of cancers where there is very poor benefit, so I find your comments entirely disengenous. How about treatments for lung cancer? They are absolutely paltry, and we dont say, whats the use, whats to be gained, let's just let them die in hospice, its better for them. Why don't you look at the number of people diagnosed per annum and the number of people that die. They are roughly the same.

I think saying something like that is completely off the wall and callous. I have a problem with you because you claim expertise and then say things that are just patently untrue. What is the importance of Provenge? Let's see, and you should know this: How about it achieves the same effect of chemotherapy while not reducing quality of life due to chemotherapy. DUH. Moreover, killing the cancer with chemotherapy obviously leads to improvement in quality of life because the tumor load is reduced?? And finally, survival is the most important clinical benefit. Why do you think the FDA thinks it is more important than reduction in disease related pain? If you cant figure this out, I dont know what to say. I know many oncologists because I have had to interact with many. All of them have wonderful attitudes as opposed to your seeming jaded sense of compassion.

Inane? I find all of your comments to be inane. They seem to be oriented towards doing nothing but stirring people up, they do not contribute to knowledge in fact they perpetuate falsehoods which is made worse by the fact that people are more likely to believe you because you claim expertise. I'm not shooting any messanger because that implies that I think what you have to say is valid. I'm shooting what I think is a detriment to this board.

And I will leave it at that.

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Author: rackled Big red star, 1000 posts Old School Fool Add to my Favorite Fools Ignore this person (you won't see their posts anymore) Number: 30801 of 70966
Subject: Re: What is to be gained........? Date: 4/26/2007 6:11 PM
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I would like to know one thing you have said that is meaningful and true.

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Author: TMFBreakerTinker Big gold star, 5000 posts Old School Fool Add to my Favorite Fools Ignore this person (you won't see their posts anymore) Number: 30802 of 70966
Subject: Re: What is to be gained........? Date: 4/26/2007 6:13 PM
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Devon, keep that foot out of the mouth.

Missash, believe it or not I concur with you on the science. However, as a medical treatment I disagree that it is not potentially significant, and that there is not enough science there to justify its approval and placement on the market. There clearly is. I think that anyone who says that there is not substantial evidence of its efficacy is not being honest. There is substantial evidence that it works. There is not the type of conclusive evidence that ODEC is use to.

Given all the surrounding circumstances there is no doubt in my mind that the correct and right thing to do is to approve this drug and make it available for patients. The only thing a 3 year delay does is produce more substantial evidence that there is substantial evidence that it works, or save insurance companies some money for 3 years from using a medication that does not work.

However, the substantial evidence that it works is such that there is a lot of supportive evidence to conclude that this is not a false positive and thereby what you are doing is delaying a safe drug, a potentially life saving drug, that we are very confidence (if not certain) that it works, just to move from very confident to certain.

Again, here is the cost/benefit equation given our level of confidence that 9901 is not a false positive:

If (.05 x Cost of false approval for 3 years) > (.95 x cost of withholding drug for 3 years if drug works)


http://boards.fool.com/Message.asp?mid=25416476

That equation is accurate and quite lopsided because the chances of a false positive are quite small, the harmful effects of Provenge are quite small, the benefit of Provenge is relatively quite large, and the result of doing nothing is quite terrible in this terminal patients. Also toss in their the intangibles of the effect of R&D in the industry, and other things Mauser has talked about vs. institutional harm, or 9902B harm that might go on the other side of the equation, and it gets even more lopsided as the reasons not to approve now are almost entirely institutional and process. The substantive reasons almost all lie on the approve side of the equation.

This is what the FDA will be looking at. ODEC wants to protect the process and institution. CDER does not have the same concerns. They want to move the process forward.


Tinker

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Author: missash Big gold star, 5000 posts Old School Fool Add to my Favorite Fools Ignore this person (you won't see their posts anymore) Number: 30803 of 70966
Subject: Re: What is to be gained........? Date: 4/26/2007 6:19 PM
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<<<<<<<<I would like to know one thing you have said that is meaningful and true.>>>>>>
How about, "Your inane comments are laughable"

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Author: rackled Big red star, 1000 posts Old School Fool Add to my Favorite Fools Ignore this person (you won't see their posts anymore) Number: 30804 of 70966
Subject: Re: What is to be gained........? Date: 4/26/2007 6:24 PM
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Good quip. You are the master of them. Care to say something with content?

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Author: missash Big gold star, 5000 posts Old School Fool Add to my Favorite Fools Ignore this person (you won't see their posts anymore) Number: 30805 of 70966
Subject: Re: What is to be gained........? Date: 4/26/2007 6:30 PM
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. <<<<<<<<<Care to say something with content? >>>>>>>. Read my posts; I've provided plenty of content; you just don't like to hear an opinion not the same as yours. I don't think I've posted anything that is, as you characterize it, "untrue". Be honest, you just don't happen to agree with me....so be it; as far as I'm concerned, this topic is closed....Good luck with your investment


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Author: franksmartin Big red star, 1000 posts Old School Fool Add to my Favorite Fools Ignore this person (you won't see their posts anymore) Number: 30807 of 70966
Subject: Re: What is to be gained........? Date: 4/26/2007 6:34 PM
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It's getting a bit Yahoo-ish around here.

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Author: cheung62 One star, 50 posts Old School Fool Add to my Favorite Fools Ignore this person (you won't see their posts anymore) Number: 30809 of 70966
Subject: Re: What is to be gained........? Date: 4/26/2007 6:50 PM
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"ODEC wants to protect the process and institution. CDER does not have the same concerns. They want to move the process forward.


Tinker"

My point almost. I just said it dumber -I said it was about "turf", oncologists' turf, which is being threatened. I am sure CDER types are working just as hard, behind the scenes, advancing their cause. But as you said, the CDERs are doing it within the institution, because right now they seemingly have the advantage within the FDA. Scher/Hussain are going public, because they are seeking allies wherever they may be.

Politics/infighting amongst doctors in academic medicine can make business seem like a cakewalk, and we are witnessing it firsthand right now. In academic medicine, it's all about prestige, and grant money; if your field is not hot, there is no prestige, and no grant money.

Ultimately, if the science behind Provenge is allowed to move forward, AND is proven efficacious, this DNDN battle will be one for the ages. Very exciting to be in the midst of it all. Truly.



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Author: capital2l One star, 50 posts Old School Fool Add to my Favorite Fools Ignore this person (you won't see their posts anymore) Number: 30813 of 70966
Subject: Re: What is to be gained........? Date: 4/26/2007 7:06 PM
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im sorry, your all missing the point.

34 percent alive at 3 years vs. 11 percent with placebo/crossover. actual 4 percent true placebo.

24 percent alive at 6 years vs 0 percent


by the way historic numbers (millions of data points) 3 percent alive at 3 years, zero at 6 years.


for 1/4 of the treated population it is a virtual cure.

jmho,

cap

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Author: 11x Big red star, 1000 posts Old School Fool Add to my Favorite Fools Ignore this person (you won't see their posts anymore) Number: 30814 of 70966
Subject: Re: What is to be gained........? Date: 4/26/2007 7:06 PM
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It's getting a bit Yahoo-ish around here.

Your mama! Time to short this pig! :)

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Author: mauser96 Big gold star, 5000 posts Old School Fool Add to my Favorite Fools Ignore this person (you won't see their posts anymore) Number: 30815 of 70966
Subject: Re: What is to be gained........? Date: 4/26/2007 7:13 PM
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That's a nice point about academic medicine which in many ways is like the rest of acedemia. Publish or perish, and to publish you need grants. To get grants, it helps a lot to be in what is perceived as a "hot" field. There's only so much money to go around, what goes into cell based cancer immunotherapy will in part be siphoned away from chemo research.
The perspective of the doctor in the trenches is different, he just wants to find some tool that he can use to help his patients. Most practicing doctors are conservative, they would prefer something where they have experience, and don't face a new learning curve. Therefore it takes new technologies a while to reach mass market, but eventually they come on board. The process isn't that much different than the technology adoption life cycle seen in other fields.
The above comments are in no way meant to be criticism of academic MDs. I've worked with them in the past, sometimes co authored papers, and have found them to be the brightest and most dedicated group of people I've ever worked with. But they do have their own set of priorites that are necessary to their milieu.

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Author: englishgeek Old School Fool Add to my Favorite Fools Ignore this person (you won't see their posts anymore) Number: 30817 of 70966
Subject: Re: What is to be gained........? Date: 4/26/2007 7:27 PM
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"I don't know if your opinion is a more philisophical question that each one must answer themselves, but I guarantee you given the chance of overcoming Prostate Cancer, many would opt to fight it any means necessary."

Count me in. My next urologist appointment is in a week and I'll demand to be first in line for Provenge. The best my oncologist can do is wait till I'm nearly dead and then offer me as fodder for his pet chemo trials.

Provenge is not the last word in PC treatment, but I'll take hope over chemo poison any day.

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Author: mauser96 Big gold star, 5000 posts Old School Fool Add to my Favorite Fools Ignore this person (you won't see their posts anymore) Number: 30818 of 70966
Subject: Re: What is to be gained........? Date: 4/26/2007 7:39 PM
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for 1/4 of the treated population it is a virtual cure
And that's with it being used in the most advanced stage of prostate cancer. Despite the statistical flaws, it would be a dreadful thing for a federal agency to turn it's back on the tens of thousands of people who could have years of extra productive life from a procedure with no harmful effects. The risk to both FDA and patients doesn't come from approval, it comes from lack of approval.

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Author: WeekendHack Three stars, 500 posts Old School Fool Add to my Favorite Fools Ignore this person (you won't see their posts anymore) Number: 30820 of 70966
Subject: Re: What is to be gained........? Date: 4/26/2007 8:31 PM
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"Read my posts;I've provided plenty of content;"

Now that is actually laughable. Truth be told I was not getting into this, however, "Posts" as in plural or to indicate in any way shape or form many with plenty of content is laughable. I had the same issues with you Missash, and now its not just me but others. You just seem bent on "quips" (very good word) that stir the nest. Most really do want to hear other's opinions, but you never really seem to be motivated to express opinions with any depth. And for someone who said they practice medicine, you do seem to struggle with some rather basic things.

WeekendHack

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Author: WeekendHack Three stars, 500 posts Old School Fool Add to my Favorite Fools Ignore this person (you won't see their posts anymore) Number: 30821 of 70966
Subject: Re: What is to be gained........? Date: 4/26/2007 8:39 PM
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"im sorry, your all missing the point."

Cap, that really is THE point along with the SAFETY. Period. The fact is there could be more than 24% still alive today, because they cut it off at 3 years and stopped tracking them. I would like to know if there are more than 24% still alive. It refers back to one of mauser's earlier posts that included "cure".

WeekendHack

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Author: AirForceFool Big red star, 1000 posts Old School Fool CAPS All Star Add to my Favorite Fools Ignore this person (you won't see their posts anymore) Number: 30823 of 70966
Subject: Re: What is to be gained........? Date: 4/26/2007 10:38 PM
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missah,


<<<<< Just an improvement in treatment, and an improvement in quality of life>>>>>> Tinker, what is the evidence that it improves the "quality of life"? Has performance status even been addressed? ( Karnofsky score or the like). I am not suggesting it should not be approved. I just don't think it is the major advance many here seem to think it is.


I agree, but would change it to say "I just don't think that its been proven to be the major advance many here seem to think it is."
Will it get there? Sure seems like it so far. Will it take some lumps along the way? Who knows, but it's possible. Will there be some data that comes out of a later trial that is either lacking, or not what we would hope for? Definately can't rule that out. Is the public gonna bid this sucker way past reasonable on good news? That's what I'm partially betting on.

Don't get me wrong, I shorted these guys after the run up... some would say I got lucky making 30% in ten days... eventually after reading a million posts, doing a lot more research, and looking hard at some expert advice from folks I trust, I slowly decided to change my position. I took out a position equal to five times what I consider a full position... then got ramped today on the drop, and added a sixth... needless to say I have an account that consists of nothing but DNDN and IMAX (this is only one of my accounts, so I am deversified, just not very much in the small cap arena).
My biggest question is what to do if there's a run-up prior to the release date. Probably sell enough shares to cover a good portion of the initial cost in case things go south... bear in mind that I have (for me anyway) an awful lot of shares. While I won't be eating salmonella tainted peanutbutter sandwiches (day old bread and free peanutbutter makes for cheap meals), it would pretty much suck.... add 2 years to the retirement clock.

Bottom line, keep posting any and all insights you might have. I would much rather wade through all possible aspects of DNDN 10 more times before news is released if it gives me even the tiniest of vectors that I didn't have before. Does it drive me nuts that this board can post almost as fast as I can read? Sure, but I'd rather wade through it all then miss something.

Chris


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Author: AirForceFool Big red star, 1000 posts Old School Fool CAPS All Star Add to my Favorite Fools Ignore this person (you won't see their posts anymore) Number: 30824 of 70966
Subject: Re: What is to be gained........? Date: 4/26/2007 10:43 PM
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Whether it turns out to be like penicillin or not in the end, this much I do know. It is highly probable that it is better than the existing gold standard in this indication for most patients.
Tinker


This says it all in my book. It gives the bull argument for approval of some sort, the exuberant ramp up in price as folks figure it is the next best thing since sliced bread (which may eventually prove to be true)... this is the point where if you listen real carefully you'll hear the zzzzzzzzzzzzzziipp of me pulling the rip cord. Hopefully I'll be wise enough to hang on to at least a normal full position (or two)

;P

Chris




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