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  • Dendreon Should Take A More Leading-Edge Approach [View article]

    Again, you are missing the fundamental point here. The current label restrictions are not a Dendreon problem, they are a systemic, FDA related problem.

    Let me try again to make this clear.

    We can agree that a potentially life-saving therapy should be available to all who can benefit from it, and, indeed, Dendreon is in the early stages of figuring out the potential benefits to be had from administering Provenge earlier in the disease process.

    The "costs" I mentioned aren't about the costs of treating a given group of patients ---- this is about the cost (in time, money, and lives) of creating and carrying out the type of trial design that is most likely to result in eventual approval and, to speak to your point, eventual label expansion once the efficacy of the drug is well-established.

    It's important for you to understand that it takes a great deal of time to properly create and set up a trial, find sites that agree to participate in the trial, recruit and screen patients meeting the criteria for the trial, track them correctly across the duration of the trial, then, compile and analyze all the data to find out whether or not the specified goals of the trial have or have not been met.

    So, speaking to current Provenge label restrictions, I reiterate the fact that creating trial designs that satisfy the FDA, especially for a brand new drug technology (like immunotherapy) is a very complicated, time-consuming and very expensive business.

    Unfortunately, it's just not as easy as picking the group that would benefit the most from the drug if it were approved by the FDA. I wish it were, but, it's not.

    Nope, among other things, it's about designing a trial that is most likely to show the type of statistical benefit that allows the drug to be approved at all, and, expanding the label from there, again, per FDA process.

    So, instead of beating up on Dendreon for something that really wasn't in their total control, go educate yourself about the details of the FDA drug approval process and the fundamentals of drug trial design for potentially terminal illnesses.

    That's a better use of your time here!

    Mar 16, 2012. 12:05 AM | 3 Likes Like |Link to Comment
  • Dendreon Should Take A More Leading-Edge Approach [View article]
    It's important for the author to understand more about exactly how Provenge came to be, especially in light of the difficulty of creating an appropriate set of trial designs in concert with the FDA - rather than criticizing the company for not doing more, sooner.

    In other words, this isn't a Dendreon "cutting edge" problem, it's a "what it takes to get a new concept drug through the system in anything like a timely fashion" problem.

    Yes, we'd all love to see what the author suggests - however, if it were truly so simple (and, if it didn't cost a ton of time and money to create and carry out these trials), it would have been done already!
    Mar 15, 2012. 12:32 PM | 6 Likes Like |Link to Comment
  • Dendreon and Fuzzy Journalism: Wherein lies the truth? [View instapost]

    If you aim to reduce the foundation a discussion regarding the statistical basis for the efficacy of an FDA approved, completely ground breaking cancer treatment paradigm to the issue of who can pay for a given treatment and who can't, we'll be in an even more sorry state than we are now, not just morally, but, economically.

    If we go down that road very far at all, pretty soon no one will be left to do any real work in this country - just hedgefund managers, sports professionals and reality TV stars. ;-)

    As things stand now, with the way we insure and deliver health care, only a very small handful of the population can even begin to afford to fund their own care (whether towards the end of a productive life or anywhere else along the continuum), no matter how well they've planned and saved, and sometimes, no matter how well they (think they are) insured.

    Not everyone can be a reality TV star, sports professional or hedgefund manager. Most people have to settle for real jobs that make an actual contribution to their communities - jobs that are rapidly losing any semblance of health benefits and wages that allow for any savings at all.

    I'd very much like medicine to move in a direction that maximizes quality of life and minimizes total cost to the system and to society as a whole. Provenge, as an active immunotherapy with minimal side effects opens the door to a way to do just that, not just for sufferers of advanced prostate cancer, but, as the pipeline grows and develops, people with breast cancer, colon cancer, etc., all of which can affect people at a variety of stages of life.

    The underlying biology of prostate cancer and the nature of the drug development and testing process made advanced PC the logical choice for Dendreon to use as a proof of concept of cellular immunotherapy before adapting the cassette technology to other uses.

    It will take some time (and money from sales of Provenge) to broaden the scope of use to other cancers that occur earlier in those potentially productive lives, but it will happen --- unless, of course, we decide to deny treatment to those who can't write a which case, then the whole immunotherapy paradigm is likely lost, forever, and we're stuck with slash and burn medical care - for everyone, at every age, for many (if not most) cancers.

    The revolutionary science behind Provenge tells me that we are on the cusp of profound innovations in health care that have the potential to save lives in a very cost effective manner.

    In the meantime, I'm just not willing to throw older (and some much younger as well) guys (most of whom have paid into the system and contributed to society for years on end) under the bus while we're getting there.

    Aug 30, 2011. 01:10 PM | 1 Like Like |Link to Comment
  • Dendreon and Fuzzy Journalism: Wherein lies the truth? [View instapost]

    Your calculator and mine seem to be working exactly the same way. :-)

    Aug 29, 2011. 11:52 AM | 2 Likes Like |Link to Comment
  • Dendreon and Fuzzy Journalism: Wherein lies the truth? [View instapost]
    If folks like Denninger are going to complain so definitively about the supposed "cost per life saved", then the knife needs to cut both ways, imho.

    To wit: we can at this point reasonably assume that a one time course of Taxotere's sum total costs are roughly equal to those of Provenge (includes estimated costs of medical support for side effects - how do you calculate the "value" of several month or more of lost quality of life, though?) ------- but, according to those same statistics Denniger twists sideways to attempt to make a point, fewer patients survive Taxotere, therefore the "cost per life" is higher....

    So, according to his reasoning, perhaps we need to dump Taxotere out of the treatment regimen right along with Provenge, especially since it costs about the same and has much worse side effects.

    Why bother spending any Medicare money at all for those with advanced prostate cancer? Nearly every man who lives long enough will get it, and, a significant number of them will end up with a form of it that causes a lengthy and horrible death (which it would seem that most men would like to avoid by some means other than taking hemlock).

    Who gets to decide who lives and who dies here, after all?
    Aug 29, 2011. 11:47 AM | 2 Likes Like |Link to Comment
  • Earnings: What Happened to Dendreon? [View article]
    Please note that Provenge doesn't "sit on the shelf until used" - once prescribed and the infusions begin, *then* the doc has to purchase it.

    Also note that reimbursement concerns have only recently been resolved - J and q codes for speedier reimbursement (as quickly as two weeks) are now up and running, and, with clarity and ease in hand, the money should flow to the prescribing docs much faster.

    There is serious ground to cover here as far as marketing and education regarding screening clients for this first in class drug - a task that is made somewhat more difficult than usual by the fact that there's not been an option for PC patients who haven't felt pain yet.

    I fault the company for how they've handled expectations, here - but the science tells me that the drug works and will in not too long a time from now have the market share it deserves (i.e., a substantial market share).
    Aug 4, 2011. 01:14 PM | 1 Like Like |Link to Comment
  • Dendreon and Provenge: What if We Lived in England? [View article]
    For those complaining about the one-time cost of $93K to extend life by 4 months - a few comments:

    This is four months median survival extension, not average (there is a difference) - a number of Provenge patients have lived months/years beyond anything currently offerred by the existing standard of care.

    If you add in the total costs of supporting a patient through the rigors of chemotherapy (multiple drugs with their own side effects along with the side effects of chemo, plus hospitalization, plus supportive care for side effects that last however long the patient manages to live), Provenge is quite competetive with existing treatments, period.

    The truly serious side effects of Provenge are nearly non-existent - relatively mild infusion reactions are most common, as opposed to chemo side effects so severe that they can cause death. Many men refuse chemo solely on quality of life concerns.

    Patients receive Provenge and resume normal life shortly therafter. They work, spend time with their families, and contribute to society in myriad ways instead of suffering.

    Better quality of life, along with longer life, for effectively the same price? Who wouldn't want Provenge?
    Jul 7, 2010. 09:20 AM | 12 Likes Like |Link to Comment
  • Dendreon: Yes, It Got FDA Approval, But Here's What It Did Wrong [View article]
    Michael, Michael, Michael:

    Watch this:

    Remember, it's four months increase in *median* survival (not average)....from ONE month (three treatments) with close to zero side hair loss, no vomiting, no horrible side effects of chemotherapy....

    What is it that you don't understand here?
    Apr 30, 2010. 11:56 PM | 12 Likes Like |Link to Comment
  • Dendreon: To Short or Not to Short? [View article]
    Please read more carefully and note that I said that it amended concerns about prior trials, *not* that it guaranteed approval.

    Big difference!
    Feb 2, 2010. 08:51 AM | 8 Likes Like |Link to Comment
  • Dendreon: To Short or Not to Short? [View article]
    As an FYI, Dendreon and the FDA agreed that the latest trial results as constructed would be sufficient to amend concerns about earlier trials.

    Also as an FYI, calling Dendreon management dunderheads and morons undermines your credibility, not theirs. They have taken careful, deliberate steps towards production and sales since the results of the IMPACT study in April, and after the 2007 debacle, would likely not have been able to secure the funds needed to construct two more plants without convincing investors that the data in hand was sufficient for approval.

    Last but not least, given the FDA modus for testing new drug methodologies, i.e., testing them on the sickest of the sick (these were, after all, men with terminal disease and only one other option with horrible side effects), a four month survival advantage is not insignificant, and your comment that this isn't a life saving treatment is premature at best, disingenuous and ill-formed at worst.

    Is a approval guaranteed? Never. Are the odds much, much better than 65/35? Absloutely.
    Feb 2, 2010. 08:17 AM | 14 Likes Like |Link to Comment