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Saul Kerpelman

 
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  • Good News for Dendreon's Provenge [View article]
    I don't think my interpretation is different than the author's--I never said a greater effect was proven, only that it looks to be likely. I also happen to have been at the CMS panel hearing and heard the author speak on behalf of Provenge and announce that they had submitted their results to ASCO. He was a very enthusuastic speaker on behalf of Provenge and seemed very excited that his results suggested even greater benefit for patients. I also am very aware that Matthew Herper has been negative on Provenge for about ten years now--almost to the point of violating journalistic ethics to give a negative bent to the Provenge story. The day before the Impact data were released he ran a story claiming that a study investigator had told him the study was going to fail. Shortly thereafter he changed the story to read "an expert". Of course then Impact unequivocally hit. He still always reports on Provenge now with the bitter sting of having been wrong about a major breakthrough treatment for ten years. Sooo--I wouldn't be quick to think that Herper is a trustworthy source for a quote from the study's author.
    Feb 20 01:07 PM | 2 Likes Like |Link to Comment
  • Good News for Dendreon's Provenge [View article]
    Yes, as above the expectation is that it will work even better in earlier stage disease. The company is running trials in earlier stages and just announced in January that they will be starting a new global study in M1 in the near future along with their European expansion plans.
    Feb 19 01:27 PM | 4 Likes Like |Link to Comment
  • Good News for Dendreon's Provenge [View article]
    But of course your disappointment is based upon the faulty premise that the absolute limit of Provenge's life extension is 4.1 months--which any true scientist would realize is just blind "statistical purity" rigidity such as denied Provenge to dying men (including your Dad?) who could have had the treatment 3 years ago. Why do you also discount the treatment as a breakthrough? Provenge validates the approach and the company is starting a trial in bladder cancer. Seems like maybe you have some anti-Provenge agenda.
    Feb 19 01:24 PM | 4 Likes Like |Link to Comment
  • Good News for Dendreon's Provenge [View article]
    Sure. Provenge is expected by just about everyone involved to work even better in earlier stage disease. The men studied so far were the sickest of the sick and already had severely compromised immune systems. Still it was able to extend life for the largest amount ever in late stage disease. There is every reason to expect that it will have even more effect in men with stronger immune systems to prime. I believe one strong reason for the CMS review was to establish that Medicare won't have to pay for Provenge off label, which scores of men are going to want. I do hope Dendreon works with EXEL on combination therapies--but I expect that given its very benign side effect profile Provenge will soon be baseline therapy.
    Feb 19 01:18 PM | 6 Likes Like |Link to Comment
  • Good News for Dendreon's Provenge [View article]
    Yes, but the "placebo" group was not that at all--it was 66% men who received frozen Provenge, which the new data suggests gave its own survival advantage. Check out how many men in the placebo group in the 9901 study made it to three years: One. It's funny you would use that standing on a chair analogy, when you're persisting in ignoring that the men in the "placebo" group were "standing on the chair" of frozen Provenge. The true benefit of Provenge is looking like somewhere around 10 or 11 months. That's not big to you?
    Feb 19 01:10 PM | 2 Likes Like |Link to Comment
  • Good News for Dendreon's Provenge [View article]
    I guess you have to back down then, because if you go and read the NEJM article they clearly set this out as the trial design--and they also comment on the fact that the salvage product group lived 14.2 months longer than the pure placebo group.

    Again on the issue of cost, we are not talking about "a few extra months"; we are talking about giving guys the chance to be in the group of treated men who lived extra years.

    By the way, you didn't answer my question whether you would want it for your Dad. It's pretty easy to favor rationing someone else's health care.
    Feb 18 10:31 AM | 13 Likes Like |Link to Comment
  • Good News for Dendreon's Provenge [View article]
    I don't think anyone's trying to build a religion. People who know the Dendreon story get frustrated at the laziness of the press in reporting "an extra 4.1 months of life" and in the next breath questioning whether "just 4 months" is worth $93,000, when in fact a man taking Provenge is hoping to be in the large group of treated men who live extra years as a result. These distinctions do make a big difference in perceptions of efficacy and price.
    Feb 18 08:37 AM | 19 Likes Like |Link to Comment
  • Good News for Dendreon's Provenge [View article]
    Wow, there's such hostility in your voice. I wonder why. Anyway you are way off base. I wasn't saying the 4.1 month MEDIAN was mathematically wrong--only that it far underestimates the true benefit of Provenge. Provenge wasn't compared to guys getting NO treatment (pure placebo), but to guys getting frozen Provenge, which today's news suggests gave its own survival advantage. Men getting NO treatment in the three studies lived 10 months less at median. So although it needs further study, the median survival advantage might be closer to ONE YEAR. And you are also ignoring the meaning of "median"--as above 32% of treated men were still alive at three years--so many men were living years and years longer. "Median" by definition means half the men lived longer than an extra 4.1 months (or 10 months, if that's the true benefit). If it were your Dad, would the chance of his living an extra year or three be worth a one time $93,000 treatment? I thought so. (Which, by the way, is less than some cutting edge chemo regimens) The K-M curves indeed go back together at 5 years because all these men are very old and very sick and eventually die. Do you require that a cancer treatment make 80 year old men live forever? As to individualized therapy I believe you are again very wrong--the company has designed very smooth logistics for treating thousands of men--and the science says NOTHING can beat getting the human body to attack its own cancer. That's the HOLY GRAIL of cancer research and Dendreon has attained it with Provenge.
    Feb 18 08:21 AM | 24 Likes Like |Link to Comment
  • Dendreon and Provenge: What if We Lived in England? [View article]
    Your post is just FUD. Provenge is FDA approved and has extended survival in 3 different phase three studies and has now been reported in the NEJM. ASCO, in its public comment to the CMS has strongly endorsed coverage. 14 of 15 local Medicare contractors have decided to cover Provenge. The "hurt the placebo group" argument has been thoroughly debunked as total anonymous nonsense by those in the know.
    Aug 10 11:09 AM | 1 Like Like |Link to Comment
  • Dendreon and Provenge: What if We Lived in England? [View article]
    If anyone coming here to read this worthless article cares to read a truthful article about Provenge and Dendreon please see my instablog posted today under the title Dendreon: Fear Is Our Friend.
    Jul 7 09:23 PM | 8 Likes Like |Link to Comment
  • Dendreon and Provenge: What if We Lived in England? [View article]
    Surprising that a "doctor" doesn't understand the difference between "average" and "median". The median is the halfway point in a series of numbers--so by definition half the men with a survival advantage in the Impact study lived longer than 4.1 extra months. Many lived for years. Eduardo Garcia was one trial subject who allowed the company to publicize that he lived an additional 9 years. Another way of looking at it is that Provenge increased a man's chances of surviving 3 years by a whopping 40%. Even these figures understate the benefit of Provenge in the study because Provenge users were not compared to pure placebo, but to a control group allowed to crossover to frozen Provenge upon progression. Compared to the men who elected not to crossover the treatment group had a 14.2 month survival advantage--the largest survival advantage ever in a late stage cancer trial!!

    Very sloppy article that proceeds from a false premise--that Provenge only "gives an additional 4 months of life". Provenge has the potential to add years to a man's life. Since it works by boosting the immune system it can be expected to work even better in men with earlier stage disease whose immune systems are not yet so compromised as the really sick late stage men in the Impact study.
    There is even the chance--expressed by the docs who ran the trial--that in earlier stage disease Provenge might render prostate cancer a chronic treatable disease and allow its sufferers to die of other causes.

    One thing I know for sure--if I had prostate cancer I wouldn't want you for my doctor.

    Sloppy, superficial work. Shameful.
    Jul 7 09:33 AM | 14 Likes Like |Link to Comment
  • Dendreon: To Short or Not to Short? [View article]
    Wow, did someone pay you to perform this hatchet job, or are you just trying to cover your own short more cheaply by spreading this FUD? Also I would really appreciate it if you could re-post this supposed article from 07 in which you predicted everything exactly as it happened back in 07--can't seem to find it in Seeking archives--but since you "made your bones" with it I am certain you would be delighted to re-post it to support the credibility of the stuff you posted today. I guess if you don't re-post I can just assume that part was a lie and today's article was just FUD. That sound fair to you? OK then. Let's see that earlier article...
    Feb 2 09:23 AM | 11 Likes Like |Link to Comment
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