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Dendreon and Fuzzy Journalism: Wherein lies the truth?

|Includes:Dendreon Corporation (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