Provenge Revenge
The FDA recently smacked men everywhere in the face, especially those suffering from metastasized prostate cancer. This came in the form of an obscure “request for more data” issued to a Seattle based company called Dendreon, which has developed a treatment for advanced Prostate cancer called Provenge.
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.
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.
posted by Iguana at 9:52 AM
6 Comments:
What are the "procedural" obstacles to Provenge approval? These obstacles must be serious and perhaps should not be dismissed out of hand.
There may be some hope for "hormone-refractory" prostate cancer patients in a new drug called Satraplatin.
The NDA was recently filed by GPC Biotech and a FDA Advisory Board hearing is scheduled for July 24, 2007.
From their press release:
"...GPC Biotech launched in February the Satraplatin Expanded Rapid Access protocol (SPERA) in the U.S. Expanded access programs are intended to give patients access to investigational drugs to treat serious or life-threatening diseases or conditions for which there are no adequate therapies available. Under the SPERA protocol, satraplatin will be provided to hormone-refractory prostate cancer patients who have failed prior chemotherapy free of charge until satraplatin is cleared for marketing in the U.S. U.S. physicians interested in receiving more information about SPERA can contact 1-800-349-8086."
http://biz.yahoo.com/prnews/070515/netu063.html?.v=8
Regardless of the outcomes of both these trials (Provenge and Satraplatin) there is certainly a critical, unmet need that MUST be addressed by the medical establishment.
Note that the primary endpoints of progression free survival in Provenge were not met, perhaps because of the late stage nature of the disease and weakened immune systems in the patients.
Potential treatments of prostate cancer web site (HRPC patient support group). Note Provenge isn't mentioned.
http://www.hrpca.org/potentialtreatments.htm
The Primary endpoints are irrelevant when you consider the endpoint of life.
The vaccine is undoubtedly proven to extend life.
The vaccine is safe.
There are no other alternatives.
Let the patients and there Doctors decide.
Satraplatin may get approval but it is for patients who fail hormone AND docetaxel chemotherapy. That means it is 3rd line treatment. It does not show much life extension and it is doubtful men who fail chemo will move to Satraplatin.
The amazing thing about Provenge was that 33% of men lived more than 36 months, when 89% of men with late stage prostate cancer die before 20 months. That is really a 16 month survival advantage (or longer), or a 300% increased odds of living 3 years.
The 4.5 median advantage is misleading, because in the Provenge studies the "placebo control" group received a less potent (frozen) version of Provenge. These men also outlived the men who take only chemo.
The FDA's decision to deny Provenge approval was horrific. It is safe. 2% of men who take chemo die from the chemo!
Dr. Petrylak, who led the chemo studies for HRPC, did a subset analysis that showed that men who took Provenge and then followed by Chemo had the best chance of living longer. SOme of the Provenge men are alive 5-7 years. It is an amazing new way to treat cancer, and the FDA decision is shortsighted. There is no known way to measure these trials, but survival cannot be faked.
Satraplatin shows a delay in tumor progression, like most chemos do, and presumably this delay correlates to survival. But in fact, with Docetaxel for example, the survival advantage is 2 months. Provenge actually showed real survival, not surrogate endpoints that are proven invalid, and that is why the FDA made an egregious error in not approving it now.
Correction to above. Among asymptomatic men who take Docetaxel chemotherapy, they have about a 2% increased chance at living 36 months or longer, as apposed to men who don't. Symptomatic men show virtually no survival advantage over placebo. These results are from the Taxotere327 trial, which is what was used to approve Taxotere for use in HRPC.
That is what is so mind boggling. There is no other treatment available. Satraplatin, if approved, won't be available unless men first fail Taxotere.
These two chemos may give a man a very slight increased chance, but at what cost to his quality of life? And then to expect him to take another chemo when that fails? What is wrong with this FDA that it seems to want to push these killer drugs on a dying population?
Provenge on the other hand appears to work better, and last longer, and be safer, and to potentiate chemo thereapy. It was a real shame that the FDA did not approve. This one was really a no brainer, and would have changed the way cancer treatments develop. It will get approved one day, but the net effect is that the FDA has sent this kind of immunotherapeutic research back many years - why is the big question and the FDA won't say. So much for transparency in government we say we want around the world, we don't even have it here.
The Unreachable Availability of Provenge
Terminal patients are those who are not expected to live due to usually illness such as advanced cancer. If the patient has 6 months or less to live, those patients are considered terminally ill. Regardless, if a patient is terminal, they are without a cure or a tolerable treatment for their illness. Since such patients will likely die in a short period of time, treatment options, even if unproven, are often desired by such patients. This is understandable, because at such a severe stage of illness, such as prostate cancer, possible extension of their lives with comfort is worth it to them, regardless of lack of evidence of proof of whatever treatment that may be advantageous to them regarding these issues. The FDA, however, claims authority on the treatment options of such patients, although that administration has proven itself over the years to be rather inadequate with its frequent drug recalls and black box warnings, and they do these things only under pressure from the public, usually. So, the FDA may not be an ideal judge regarding such issues as treatment options for very sick patients.
Prostate cancer is rather frequent, with between 10 to 20 percent of men predicted to acquire the disease during their lifespan, resulting in about 30,000 deaths a year from this disease. Furthermore, there are different stages of prostate cancer, and the more severe the prostate cancer cases are, which is determined by such methods as bone scans and Gleason’s scores, the more difficult it is to treat such patients.
Yet innovation still exists in medicine. A few years ago, a small Biotechnology company called Dendreon was working on a conceptually new treatment for the worst prostate cancer patients, and this treatment therapy created by Dendreon was named Provenge. Provenge is the first immunotherapy biologic treatment for the progressed prostate cancer patients. Usually, these patients are unresponsive to usual treatment methods for prostate cancer, and are left with chemotherapy as their only treatment option at such a traumatic stage of prostate cancer. Understandably, most patients at this stage refuse treatment entirely, largely due to the brutal side effects of such chemotherapy treatments as Taxodere. The immunotherapy method developed by Dendreon requires the removal of white blood cells of the diseased patient and, after altered, are re-injected into this patient now designed to attack within the diseased body what is called PAP, which is on prostate cancer cells only. This treatment requires only three such injections in a period of six weeks. This results in life extension twice that of chemotherapy treated prostate cancer patients of this severity, and without the concerning side effects of chemotherapy. The medical community and survivors of prostate cancer were elated and waited with great anticipation for access to this treatment method.
Fortunately, as the years passed, Provenge, by 2007, had convinced others of its safety and efficacy in its benefit for severe prostate cancer patients. This caused great joy to such patients and their families. Perhaps greater elation was experienced by the caregivers and specialists of such a disease, such as Urologists and Oncologists who treat such patients. While Provenge was on fast track status at this time at the FDA, the FDA panel recommended with clarity the approval of Provenge based on its proven and substancial efficacy and safety demonstrated in its trials, as they announced in March of 2007. This was expected by many, as Provenge was given Fast Track status by the FDA because of the potential of this therapy for terminal patients.
Now for the bad news: With great shock and surprise, the FDA agency rejected the approval of this great treatment for very sick patients due to, they said, ‘lack of data’ in May of 2007. This contradicts their favorable opinion of Provenge weeks before delivering this terrible news. Especially when one considers the FDA Commissioner is a prostate cancer survival himself! Many found this ruling completely unbelievable.
Soon after this judgment was passed by the FDA, conflicts of interest were discovered by others. For example, a member of the FDA agency who was evaluating Provenge, Dr. Scher, was found to have a financial commitment to a future competitor of Provenge that was being produced by a company called Novacea, and this company had signed a co-promotion agreement with Schering to provide support for this similar prostate cancer drug treatment being developed by this company. Dr. Scher never disclosed this conflict during the approval process of Provenge. As it turns out, this anticipated prostate cancer drug made by Novacea was discovered to have serious flaws, and Schering pulled out of the agreement with Novacea. In addition to this incident and before May of 2007, baseless letters were anonymously delivered to the FDA stating negative qualities about Provenge that were without Merit and speculative claims about the treatment were fabricated in these letters, it is believed. Yet overall, the disapproval by the FDA of Provenge angered many, and a newly formed advocacy group called Care to Live filed a lawsuit against the FDA for their clear lack of protocol or knowledge about such complex treatment agents as provenge at the end of last year.
Terminal patients, I surmise, desire comfort during their progressive disease that has placed them in the last chapter of their lives, and certainly should have a right to choose any treatment that possibly could benefit them. Because most are willing to assume any risks of unapproved, yet potentially beneficial treatments such as Provenge. Because they have a terminal illness, possible benefits clearly take priority over safety issues of unapproved treatments for them. The controversy could be concluded by a terminal patient signing a waiver of some sort, perhaps, stating that they are responsible for the consequences of an unapproved treatment regimen such as Provenge. Yet the FDA, with reckless disregard and overt harshness, denied what likely was a great treatment method for these very ill patients, so the FDA ultimately harmed others more by not approving Provenge, or offering any exceptions with such cases, which in this situation seems most rational, considering the available data with Provenge.
The FDA does in fact presently have the ability to grant what is called conditional approval for such treatment methods as Provenge at this time, and why they have not remains completely unknown. What is known is that they are harming those they pledged to protect so long ago. So now the FDA appears to be a bought, corrupt, and incompetent administration without loyalty and dedication to the public and its health. This needs to be corrected in any way possible for the lives of others, regardless of thier present health state today. Because of the FDA's flaws in the past regarding drugs taken off the market along with increasing black box warnings of other drugs, which happens often with both, the individual should be the deciding factor in such matters of deciding thier treatment course along with thier health care provider, and not an unreliable Administration.
“Facts do not cease to exist because they are ignored.” --- Aldous Huxley
Dan Abshear
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