FDA fails to think, applies wrong lessons to Provenge

Found this excellent comment at http://www1.investorvillage.com/smbd.asp?mb=971&pt=msg&mid=2125129

The FDA willingly, openly exposed themselves with this decision by employing a less than logical risk/reward model for terminally ill patients. When safety is a near given, the risk becomes almost non-existent. Hence, the reward becomes more practical in terms of application. And in this case for an even better reason - the therapy works and the patients are afflicted with late-stage disease.

The end-point criteria that has been at the crux of the argument would make much more sense for otc products, or safety insufficient therapies, etc. - Marginalizing the condition of advanced prostate cancer, by minimizing the condition with this given peer set, is where the disconnect of logic by the FDA exposes itself and shouts to the rooftops - "we aren't about what we say, we are about what we do, and that is providing chemo agents to this patient class, and chemo agents only." Remember what the response from Hussein was in regard to the patient advocate who asked for a novel alternative for pc patients? "You can have Taxotere."

Let's reverse the scenario of applying the same standards to chemotherapy as are exhibited by Provenge. That association, of course, would really undermine the objective of the chemo-cartel. First of all we know chemo is not "Safe." Secondly the end-point they are so in love with has a major downside as well. Poisoning the patient guarantees that a given tumor will also be forced to deal with poison. Yes, you are almost awarded an automatic outcome of delay in disease progression with the poison, but at the same time you unfortunately have compromised the patient's system/body in other serious regards. Where are the risk/reward leveraged from in that analysis of feasibility?

The cartel has rendered any therapy believed to be "Safe" as also ineffective, simply because the existing standard dictates you must inflict damage to the overall patient to have success with the disease. Any other concept will be regarded as substandard if the given therapy does not retain this denominator, thus no other approach is ever going to provide a parallel outcome, and there is no flexibility / means to incorporate deviation.

The outcome for chemotherapy is championed because a simple observation says "see the tumor is smaller. We know the patient is less healthy, but so is the tumor." We can understand that as an application, but suggesting not poisoning the patient doesn't make sense (with their logic). If the patient can't be poisoned then how can the mechanism be effective on tumor growth?" This is the small circle the cartel stayed well within until they were recently forced to expose their agenda for basic economical survival.

This approach, although a simple and convenient mindset, has allowed the cartel to avoid / forgo the concept that attacking the disease could actually originate in a different form, with a different mechanism and outcome AND methodology for assessing progress, for either patient or disease. The phenomenon of a different class of agent so close to threatening their ideals is what has forced the chemo-cartel into exposing themselves as they have the past month. They deployed their last line of defense even at the risk of exposing their protectionist agenda. I believe they felt that threatened by Provenge and subsequent related therapy. Their offering was simply... Immunotherapy does not work simply because those agents do not work like chemotherapeutic agents.