To make a long story short, Dendreon has carried Provenge through Phase 2 clinical trials. In a double blind study, these trials showed men treated with Provenge lived on average 4.5 months longer than men treated with placebo. An advisory panel to the FDA voted 17-0 that Provenge was safe. Moreover, the panel recommended 13-4 that the FDA approve Provenge for treatment of prostate cancer. Of the 4 dissenters, the most vociferous was a female doctor who was primarily concerned with "procedure."
There currently are no options available to men with metastasized prostate cancer. When prostate cancer is first identified, the typical treatment is to remove the prostrate, at the risk of the patient loosing not only the ability to have an erection but also bladder control. After that all that is left to do is to pray that no cancer cells leaked into the lymphatic system and have spread. From that point forward, the typical treatment is to put these men on a regimen of estrogen treatment.
Dendreon’s Provenge promised an alternative; one that has been clearly shown to increase the lifespan of men with prostate cancer. While 4.5 months of life extension may not seem like much, it is worth life itself to men with metastasized prostrate cancer. And, remember, the men that made it into the study groups were those in the most advanced stages of the cancer. Provenge works by harnessing the body’s own immune system to attack the cancer. If men were given this treatment earlier in the cancer’s development, and prior to the cancer spreading to the extent of those men in the studies, their immune systems may have more time to fight the disease and curtail it’s spread while it is still manageable. For information on how the treatment works, consult Dendreon’s web site.
In typical oblique fashion, the FDA did not make public its reasoning for delaying availability of the drug. But, have no doubt, if a drug as promising as Provenge had reached this stage for the treatment of breast cancer the outcry from NOW and every other feminist organization would be deafening. In fact, with the NIH spending the vast majority of its cancer research funding on breast cancer (prostrate cancer is hardly on the budget), I doubt the FDA would have delayed the introduction of a treatment for breast cancer that showed the results of Provenge.
Now, instead of gearing up to provide Provenge to millions of men in need, Dendreon has been forced to lay people off in order to conserve cash. And pray that the FDA provides approval before they run out of cash and the treatment is lost to the world.
Once again, we see that men have no advocates in government. Isn't it interesting that while Dendreon is a Seattle based company, and the state's governor has proclaimed that the State of Washington will be a center of bio-medical research and development, our two women Senators - Maria Cantwell and Patty Murray - have uttered not a peep. Because the NIH pays little attention to any cancer other than breast cancer, men must rely on the private market to respond to our need for effective prostrate treatment. Instead of helping, the FDA has become a roadblock. Companies like Dendreon cannot sustain losses in perpetuity while trying to meet all of the FDA’s sometimes ridiculous and often inconsistent requirements.
The FDA should have followed it’s own expert panel's recommendations. In the meantime, millions of men who could be receiving the treatment are left taking estrogen while watching their cancer advance and counting down the days to their death. And, with prostate cancer, which spreads to the bones, death is extremely painful.
The FDA should hear your complaints about their insensitivity. They should hear the stories of your friends with prostrate cancer, or your own story if you have the disease. They should hear that it is not acceptable to delay Provenge just so they can have procedural perfection when the treatment has clearly shown efficacy after Phase 2 testing.
Go here to file your complaint with the FDA.
And, while you are at it, go the the US Senate web site and complain to Maria Cantwell and Patty Murray for their silence on this matter. Remind them that they are supposed to be representing both "genders" of the State of Washington while in the city of Washington as well as Washington State based companies, such as Dendreon.
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