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Theodore J. Cohen, Ph.D., a research scientist, has been an investor for more than 50 years. Since 1980, he has focused his attention on investment research and investigative analyses of companies developing therapeutic drugs in the biotech sector. Dr. Cohen is a frequent contributor of Guest... More
My book:
Death by Wall Street: Rampage of the Bulls
  • Dendreon and Fuzzy Journalism: Wherein lies the truth? 17 comments
    Aug 29, 2011 7:37 AM | about stocks: DNDN
    Between 1980 and 1984, my wife and I wrote and voiced more than 500 90-second radio features―Report on Personal Computers―for WTOP AM-1500, a 50,000 Watt clear-channel station in Washington, DC. (Selected features were aired by the CBS Radio Stations News Service and Canadian Broadcasting Corporation.) We used to joke that WTOP, a 24x7, all-news station with a large complement of staff reporters and editors, was significantly different from the usual “rip-‘n’-read” AM radio stations that dotted the US landscape. The latter had only one person running both the transmitter and the station board. As such, it was his or her job, at 55 minutes past the hour, to run to the teletype machine and rip the news from the station’s news service (e.g., AP, UP, etc.) off the printer. From there, it was back to the microphone, where this all-in-one engineer-announcer cum news reporter would read the news, without concern for the truth!
    That was 30 years ago. Yet today, many newspaper, radio, TV, and cable news commentators as well as Internet reporters and bloggers (professional and otherwise) still follow the practice of “ripping” the news off the ‘wire’ (basically, from whatever source is available) and presenting it to their readers, listeners, and viewers without verifying the information presented.
    The rush to be first with a story often creates such issues. But all ‘news organizations,’ be they newspapers, radio and television outlets, cable broadcasters, and legitimate news-oriented Internet sites as well as otherindependent news and information Web sites,have an implied requirementeven a burden, if you willto “get it right” the first time. Failing to do so not only can result in the promulgation of incorrect and potentially damaging information, but also, can destroy credibility and even lives (in the case where erroneous information or intentional disinformation is spread regarding medical treatments).
    The lack of concern for the truth in the media conjures up visions of Yellow Journalism. Unconstrained, it can cause grave harm to the reader and the public at large. You do not have to look far for examples. As a veteran of the ‘Provenge Wars,’ I am all too familiar with the ongoing battle over the infamous ‘four month’ extension in life that so many seem to associate with Dendreon’s immunotherapeutic treatment for end stage prostate cancer. Time and time again those who understand the results have attempted to educate laypersons and the medical community alike as to what the results of Dendreon’s drug trials really mean. Yet, as late as last week, examples of published misinformation regarding the potential life-extension from Provenge, ‘fuzzy journalism,’ if you will, still were being broadcast on the Internet, trivializing this immunotherapy’s benefits.
    Today, there is no excuse for the continued dissemination of such misinformation. If a reporter is going to write about Provenge, then he or she owes it to their readers to present the truth. Now, this is not to say that they are not entitled to voice an opinion regarding the treatment, whatever that may be. Reporters are entitled to their own opinions, on Provenge or on any other drug or treatment. However, they are NOT entitled to their own facts.

    I am going to assume that reporters of all stripes who focused erroneously on a ‘four month’ life extension from Provenge have done so either because they ‘ripped’ the result from some other document or because they simply did not understand basic math, much less the statistics involved. So, perhaps those in the media (and others) who read this Blog might find the following discussion helpful when it comes to describing the benefits of Provenge:

    Instead of talking about a 4.1-month MEDIAN—not average—survival advantage demonstrated in the pivotal, 512-patient Phase 3 IMPACT study (which, admittedly, some people find difficult to understand because of the statistics involved), perhaps it would be better simply to talk about a 38% improvement in 3-year survival (31.7% survival rate at three years on the treatment arm compared to 23% for the control arm) and/or a 22.5% improvement in risk of dying. Put another way, the odds of a patient treated with Sipuleucel-T, which is the generic name for Provenge, surviving at 3 years was about one in three comparing to the odds of about one in five for an untreated patient. Think about it this way: If you are a man 70 years old or older with metastatic prostate cancer, would you consider a treatment that would give you a chance of one in three to live 3 years longer instead of doing nothing and taking a chance of one in five or even less of living that long? I know what my answer would be!

    Results from the similarly designed Phase 3 Study D9901 in asymptomatic metastatic castration-resistant prostate cancer (CRPC) also demonstrated a survival advantage of similar clinical magnitude as the IMPACT study.
    This level of efficacy coupling with a mild side effect profile—mild flu-like symptoms—was remarkable when compared to the current standard of care, the chemotherapy Taxotere, which showed only a 2.5 months median improvement with possibly debilitating side effects.

    Furthermore, it should be noted that in contrast to other trials, including the ones for Taxotere, patients on the control arms of the Provenge trials were allowed to cross over and take a weaker form of Provenge after disease progression. This could exaggerate the survival rate and the median survival time of patients on the control arms. That is, the 4.1 months median difference or the 22.5% improvement in the risk of dying, could be much better if the control arm of the IMPACT trial was using a pure placebo. For example, in a recent study presented at the ASCO 2011 Symposium (see this abstract), it was found that the median survival times were respectively 20.0 months and 9.8 months for patients who crossed over to the weaker form of Provenge and patients who did not receive any form of Provenge. Patients who crossed over also had 48% less risk of dying than those who did not. These data are substantiated by material submitted to the FDA by Dendreon, and are available in the archival literature.

    Finally, a good tutorial on Provenge for those interested in how the treatment works can be found here. For reference, there currently are 656 sites authorized to administer Provenge. For more information, see Dendreon's Provenge site.
    I recognize that the easy way out for most reporters, bloggers, and others is simply to talk (erroneously) about a ‘four-month’ life extension for Provenge. But it is incorrect to do so and only shows ignorance of the subject…perhaps, even, to the detriment of patients who could benefit from Provenge. Think about it. Spreading false information about any treatment, even unknowingly, can kill if even one patient makes an incorrect, life-determining decision based on something you wrote.
    Disclosure: I am long DNDN and will not alter my position within 72 hours of the time of publication of this article.
    Theodore J. Cohen, Ph.D., is the author of the novel Death by Wall Street: Rampage of the Bulls.
    Stocks: DNDN
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Comments (17)
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  • Karl Denninger
    , contributor
    Comments (301) | Send Message

    29 Aug 2011, 09:09 AM Reply Like
  • Theodore Cohen
    , contributor
    Comments (2176) | Send Message
    Author’s reply » Ah, a slippery slope, indeed, my friend.


    An associate sent me the following comment shortly after you penned your screed: "Suppose, shortly after he wrote that article, he suffered massive chest pains. Emergency procedures lead him to the OR and a possible triple bypass. Estimated costs: $60,000 to $120,000. Is he going to pay for it or refuse it?"


    I didn't know what to say?
    29 Aug 2011, 11:26 AM Reply Like
  • Karl Denninger
    , contributor
    Comments (301) | Send Message
    I made my choice before I suffered the pains, eh? Perhaps I choose to buy health insurance, perhaps I do not. Perhaps I have $60,000, perhaps I do not.


    What part of "make decisions and benefit or suffer from the consequences" is so difficult? From exactly WHERE do you derive the right to STEAL the funds from someone else once you have made the decision NOT to provide for these treatments on your own?


    As we age we will ALL require health care. If you look at the statistics you are odds-on as a male to have prostate cancer by age 80. It's just that for most men something else kills you first - but if you draw the unlucky card, it gets you.


    Ok, this is a known fact. So either start socking away funds at age 20 for this fact and to mitigate the risk of drawing the unlucky card, or not. You choose, you take the benefit or suffer the risk.


    The problem with Dendreon and many other so-called "wonder drugs" is that without the ability to shove a gun up someone else's butt and force them to buy the drug or other treatment there's an insufficient market, as too few people will **OPT** to take $100,000 from their kids inheritance (or whatever else they'd choose to spend it on) for a 1-in-10 enhancement in the chance of "making it."
    30 Aug 2011, 08:45 AM Reply Like
  • smakit
    , contributor
    Comments (93) | Send Message
    Denninger is are wrong......all there is to it.
    29 Aug 2011, 10:55 AM Reply Like
  • Theodore Cohen
    , contributor
    Comments (2176) | Send Message
    Author’s reply » Thanks for your comment. Ted
    29 Aug 2011, 11:22 AM Reply Like
  • moonshooter
    , contributor
    Comments (9) | Send Message
    >"Right. The drug is pretty much a binary - you either benefit from it or you don't. But let's not mince words here - out of a population of 100 metastatic prostate cancer patients roughly 23 of them will be alive three years hence without the drug while with it nine more will survive.Nine.


    That is, out of the entire sample of patients the incremental improvement in three-year survival is nine percent, not 22.5%. That is, the outcome is binary - you either survive or don't. And Provenge can only be credited with nine saves, not 32, since the other patients survived the three years without it."<




    Let's see now...............


    9 patients divided by 23 patients equals .39 or 39% improvement over the number that survived 3 yrs without Provenge according to my trusty little Texas Instruments solar calculator. (Is my calculator working properly?)


    Hmmm,....I think maybe the fellow complaining was just posting to pump his website! Maybe....??? ;-)
    29 Aug 2011, 11:37 AM Reply Like
  • Gentlewoman
    , contributor
    Comments (10) | Send Message


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


    29 Aug 2011, 11:52 AM Reply Like
  • Gentlewoman
    , contributor
    Comments (10) | Send Message
    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?
    29 Aug 2011, 11:47 AM Reply Like
  • Karl Denninger
    , contributor
    Comments (301) | Send Message
    You do. With your checkbook.
    30 Aug 2011, 08:46 AM Reply Like
  • Gentlewoman
    , contributor
    Comments (10) | Send Message


    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.


    30 Aug 2011, 01:10 PM Reply Like
  • Theodore Cohen
    , contributor
    Comments (2176) | Send Message
    Author’s reply » Good point, GW! David Miller showed that when you take into account the treatment of Taxotere's side effects, the cost of treating end stage prostate cancer with either Taxotere or Provenge is about the same.



    Here are the details:


    Taxotere Side Effects:


    Important things to remember about Taxotere side effects:
    •Most people do not experience all of the Taxotere side effects listed
    •Taxotere side effects are often predictable in terms of their onset and duration
    •Taxotere side effects are almost always reversible and will go away after treatment is complete
    •There are many options to help minimize or prevent Taxotere side effects
    •There is no relationship between the presence or severity of Taxotere side effects and the effectiveness of Taxotere.
    •Taxotere side effects and their severity depend on how much Taxotere is given. In other words, high doses of Taxotere may produce more severe side effects).


    The following Taxotere side effects are common (occurring in greater than 30%) for patients taking Taxotere:
    •Low white blood cell count (this can increase your risk for infection)
    •Low red blood cell count (anemia)


    Nadir: Meaning low point, nadir is the point in time between chemotherapy cycles in which you experience low blood counts.


    Onset: 4-7 days
    Nadir: 5-9 days
    Recovery: 21 days

    Fluid retention with weight gain, swelling of the ankles or abdominal area.


    Peripheral neuropathy (numbness in your fingers and toes) may occur with repeated doses. This should be reported to your healthcare provider.


    •Mouth sores
    •Hair loss
    •Fatigue and weakness
    •Nail changes (color changes to your fingernails or toenails may occur while taking Taxotere. In extreme, but rare, cases nails may fall off. After you have finished Taxotere treatments, your nails will generally grow back.)


    These Taxotere side effects are less common, meaning they occur in 10-29 percent of patients receiving Taxotere:
    •Muscle/bone/joint pain (myalgias and arthralgias)
    •Low platelet count (This can increase your risk of bleeding)
    •Increases in blood tests measuring liver function. These return to normal once treatment is discontinued. (see liver problems)


    Infusion-related Taxotere side effects (symptoms which may occur during the actual treatment) include:
    •Allergic reactions (rash, flushing, fever, lowered blood pressure). Happens rarely, usually occurs in the first or second infusion. Frequency is reduced by premedication with corticosteroid starting one day before infusion. You will be monitored closely during the infusion for any signs of allergic reaction.
    •Infusion site reactions (uncommon and generally mild, consist of darkening of the vein, inflammation, redness or dryness of the skin, or swelling of the vein).


    Not all Taxotere side effects are listed above, some that are rare (occurring in less than 10% of patients) are not listed here. However, you should always inform your health care provider if you experience any unusual symptoms.


    Compare that to the side effects from Provenge:


    Side Effects of Provenge - for the Consumer




    All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Provenge:


    Back pain; fatigue; headache; joint aches; mild pain, fever, or chills; nausea; weakness.
    Seek medical attention right away if any of these SEVERE side effects occur when using Provenge:



    Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); burning, numbness, or tingling; chest pain; confusion; fatigue; fast or irregular heartbeat; fever, chills, or sore throat; muscle spasms or aches; one-sided weakness; redness or pain at the injection site; severe joint aches; severe muscle pain, weakness, or cramping; severe or persistent dizziness, headache, or nausea; shortness of breath; slurred speech; tremors; unusual tiredness or weakness; vision problems; vomiting.


    This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.


    What would you chose if you had end stage prostate cancer and no other alternatives? I know what my choice would be.


    Or are we about to enter an age when for every disease, a panel not only will decide which treatment will be provided, but which patients will live and which will die. Is this the World of 2084?
    29 Aug 2011, 12:04 PM Reply Like
  • ahasuerus99
    , contributor
    Comment (1) | Send Message
    That is precisely Mr. Denninger's point, I believe. We should drop Taxotere as well, and all persons with advanced prostate cancer should only receive the treatment they are personally capable of paying for. So yes, there is no reason to bother spending Medicare money on those with advanced prostate cancer.


    Evidently also the two other posters do not understand incrementals.


    And the author himself is not even attempting to refute Mr. Denninger's point, which is all we should need to know about who is right and who is wrong. Instead, he relies upon the tried and true appeal to emotion and ad hominem. You basically accuse Mr. Denninger of being a hypocrite who would support wasting tax payer dollars on his own care with no evidence to support your screed. It also doesn't help that you compare a triple bypass, after which the life expectancy and quality of life can be exceptional, with late stage prostate cancer.
    29 Aug 2011, 02:15 PM Reply Like
  • Mourad Zarouri
    , contributor
    Comments (306) | Send Message
    Ahasue... you are full of you know what.... The title of the article is..


    "The Dendreon Pumpers Will Not Quit"


    It doesn't say the Taxotere Pumpers will not quit!!!!
    29 Aug 2011, 02:38 PM Reply Like
  • Theodore Cohen
    , contributor
    Comments (2176) | Send Message
    Author’s reply » Ahhh, Dear ahasuerus99...


    My piece was intended to address the issue of 'fuzzy journalism' and those in the media who either simply take their stores from others without understanding what they are writing or who do not understand how to interpret the data or information about which they are writing. It was Mr. Denninger who made the decision to change the topic of our discussion to one of price and who is to be treated (or not). Simply because I have decided not to refute Mr. Denninger's point says absolutely nothing about the position I may, or may not, take on the subject. Are you always in the habit of speaking for others?


    But if you want an answer from me, here it is: Provenge, approved by the FDA, was subsequently approved by the CMS for end stage prostate cancer. On August 3, 2011, CMS published a National Coverage Determination (NCD) that clarifies reimbursement of PROVENGE for Medicare beneficiaries. A final J-Code will be issued January 1, 2012. As long as CMS and other insurance providers pay for the administration of Provenge, Taxotere, or any other medication for prostate cancer or any other disease--be that insurance Medicare, Medicaid, Blue Cross/Blue Shield, or any other insurer--then what you, Mr. Denninger, or I think doesn't matter, does it? It's the law. And while we each can have an opinion, and certainly, are free to voice it in fora such as Seeking Alpha and elsewhere on the Internet, in the end these reimbursement policies are not going to change without action at the federal level.


    Thanks for your comments.


    29 Aug 2011, 03:09 PM Reply Like
  • Karl Denninger
    , contributor
    Comments (301) | Send Message
    Oh yes they are.


    The money simply doesn't exist to fund Medicare with these expenditures. The wet dreams of the pharma industry are running smack into the reality of fiscal failure.
    30 Aug 2011, 08:47 AM Reply Like
  • falanke
    , contributor
    Comments (78) | Send Message
    Prior to the arrival of Provenge, how many people were on Taxotere each year?
    16 Sep 2011, 11:05 AM Reply Like
  • Theodore Cohen
    , contributor
    Comments (2176) | Send Message
    Author’s reply » For PCa...I have no idea. And I'm not sure how one would go about obtaining that number, given that it's used both on- and off-label to treat patients of this indication. I wish I could give you a better answer.


    That said, look at these data:
    Estimated new cases and deaths from prostate cancer in the United States in 2011:
    New cases: 240,890
    Deaths: 33,720


    One would have to believe that the number treated with Taxotere each year is in the tens of thousands.


    I wish I could give you a better estimate.




    16 Sep 2011, 11:23 AM Reply Like
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