On March 29, an FDA advisory committee overwhelmingly determined that Provenge, Dendreon's immunotherapy directed against prostate cells following prostatectomy in advanced metastatic prostate cancer, is safe and has shown substantial evidence of efficacy, the two criteria Congress authorized the FDA to consider in approving drugs. It was therefore a surprise when the FDA announced on May 9 that it would require further proof of efficacy before approval, which may require waiting for clinical trial results that are 3 years away.
This is the first time in memory that the FDA has ever gone against a committee recommendation to approve a drug for a terminal condition. But most importantly, by forcing a delay of 3 more years to confirm something that already has a 99% chance of certainty, this decision will condemn tens of thousands of men to die earlier and unnecessary deaths. If it still insisted on further proof of efficacy, the FDA had the authority to allow marketing immediately with a postmarking commitment to complete the ongoing trial and revoke authorization if necessary, but the FDA did not pursue this possibility. This delay is therefore neither justified nor necessary.
To make the situation even more difficult to understand, there are plenty of cancer drugs in our armatarium that have never demonstrated a survival benefit, or even been tested in randomized controlled trials, prior to approval. Congress could not have possibly meant in establishing guidelines for the FDA that a drug that triples survival after 3 years, that has shown evidence of efficacy in 4 other trials, that has no side effects, and that is superior in all ways to existing drugs, should not be approved!
This (tragic, in my opinion) decision by the FDA may stem from problems in its organization or leadership. The FDA Commissioner, Dr. Andrew Von Eschenbach, said the FDA would be a bridge rather than a barrier to new therapies, and would attempt to get cancer drugs to patients as quickly as possible. In light of the decision to delay Provenge, Dr. Von Eschenback’s statements lack credibility. In addition, two doctors who had been on the advisory committee, despite having financial interests in companies developing more toxic competing therapies, waged an unusual campaign of disinformation against Provenge approval. That a few people can go outside of their predesignated roles at the FDA, hijack the Provenge approval process, and harm thousands of seriously ill patients would be a true travesty.
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2 comments:
Dr. M ,
I am so glad I found this blog. You explanations are easy to read, clear, very believable and thorough.
I might have to plagiarize your work! Just kidding Dr.
I will certainly refer others to this Blog of yours.
My Blog is only meant to be a hub of information. Although I hope to write something brilliant which can represent my passion for doing what is right.
Keep it up and
ProvengeNow!
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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