Provenge Activists Seek US Supreme Court Review
5 CommentsBy Ed Silverman // October 27th, 2008 // 9:00 am
Two months after being rejected by the a federal appeals court, a group of prostate cancer patients and investors have asked the US Supreme Court to allow them to proceed with a lawsuit against the FDA over its handling of the Provenge prostate cancer vaccine.
They filed their case last year, after the agency unexpectedly rejected the recommendation of its advisory committee, causing considerable controversy. The lawsuit alleged undisclosed conflicts of interest by two FDA advisory committee members, who wrote FDA officials to urge a go-slow approach, and Byzantine agency politics involving the head of the oncology drugs office.
The US Court of Appeals for the Sixth Circuit in Cincinnati rejected arguments that judicial review was required because of a lack of transparency and accountability in the way the FDA decided to delay approval for the vaccine, which is being developed by Dendreon. Here’s the petition filed with the US Supreme Court.
Dan A.
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 The 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. It is the third most common cancer one can acquire, and the United States has the most cases diagnosed n the world, which usually strikes men past the age of fifty. One million do have prostate cancer in the United States, and about thirty thousand will die from the disease each year. Furthermore, there are different stages of prostate cancer, and the more severe the prostate cancer cases are, the higher of what are called Gleason Scores will be, and the severe cases are the most difficult to treat, of course.
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, specifically a hazardous drug called Taxotere, 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, which include cytotoxic side effects and haematological adverse events. 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 Taxodere, and Provenge is free of the discomfort of the only other treatment of Taxotere. 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 other caregivers who treat such patients. While Provenge was on fast track status at this time at the FDA, as they at the time agreed with the benefits of this new therapy, the FDA panel recommended with clarity the approval of Provenge based on its proven and superior efficacy and safety that was demonstrated in its trials, as they announced in March of 2007. Lifespan extension of severe prostate cancer patients was twice as long with Provenge versus Taxotere, which is the only other treatment indicated for this stage of prostate cancer that had only superficial efficacy, and is free of the toxic effects of this chemotherapy agent.
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 Oncologists were speculated to lobby and pressure the FDA not to approve Provenge due to anticipated revenue loss. Yet overall, the disapproval by the FDA of Provenge angered and saddened many, and a newly formed advocacy group called Care to Live filed a lawsuit against the FDA for their clear lack of etiology for not approving Provenge, as they should have, according to the data about the therapy 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. Clearly, because of their lack of desirable and beneficial treatment options, most are willing to assume any risks of unapproved, yet potentially and likely beneficial treatments such as Provenge.
Because they have a terminal illness, these benefits provided by Provenge take priority over any possible 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 with deliberate intent, denied what likely was a great treatment therapy for these very ill patients. Several have concluded that the FDA ultimately harmed others more by not approving Provenge, or offering any valid explanations explaining their action. Thier action was irrational, as one considers the agreement of the FDA and others regarding the need of the benefits provided by Provenge for the sickest of the sick with advanced prostate cancer.
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 accelerating and worsening the illness, an illness the FDA 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, but with what appears to be overt collusion with venture capitalists and corporations. This needs to be corrected in any way possible for the lives of others- regardless of their own 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 presently, along with their health care provider, due to this unreliable administration called the FDA.
“Facts do not cease to exist because they are ignored.” — Aldous Huxley
Dan Abshear
kyoto27
How sad that while a group of prostate cancer patients petitions the Supreme Court, our ‘science based’ FDA has yet to even condemn the very unscientific assault on Provenge in The Cancer Letter by doctors who sat on the Provenge advisory committee. Is the FDA afraid to follow the truth? Not the best MO for a science based agency, and begs the question whether the FDA has even bothered to investigate the alleged conspiracy, or the bazaar behavior of Dr Richard Pazdur in the Provenge saga. Perhaps now that Congress is focused on the aftermaths of an ‘unregulated’ Wall Street…it may also want to look at the human cost to America of an unregulated FDA. The House of the People –before the Supreme Court, should be outraged at the FDA’s absence of mind and leadership….
Tanin
Unless Dendreon reveals the comments of the non-approval letter to the public, I believe it is not appropriate to second guess the FDA. All this discussion about the advisory committee politics is very interesting but it is also a distraction, for all was know the FDA could have rejected the drug for very real and very good reasons (and it is up to Dendreon to disclose this information).
Jack
A great many people now suspect that something went very wrong with the advisory committee process for Provenge, and there are names attached to those suspicions. If my name were one of them, I would be calling very publicly for an investigation to show that I did not corrupt the process.
However, there is substantial evidence to suggest that the advisory committee process was in fact corrupted. An investigation should have been conducted by the FDA.
Concerned patient interest groups have directly asked the highest levels of the FDA whether the FDA has conducted their own investigation of what happened, in person. They declined to answer the question.
The FDA has acted too slowly in resolving this issue. Even in responding to FOIA (Freedom of Information Act) requests, the FDA has stated that they can not reply timely because it is overburdened!
In August, the Court of Appeals court denied discovery of further wrong doing to continue because the case was “unripe”. Justice delayed is justice denied! This principle is the basis of the right to a speedy trial.
Congress was asked to investigate irregularities in the advisory committee process; specifically, whether two of the advisory committee members that were placed onto a Center for Biologics Evaluation and Research (CBER) advisory committee by managers in the Center for Drug Evaluation and Research (CDER) failed to disclose important financial conflicts of interest required to be disclosed by written FDA policy in place at the time. While the aggressive letter writing campaign by those two members (that occurred after the advisory committee hearing where the committee voted unanimously that Provenge was safe, and 17 to 4 that substantial efficacy had been demonstrated by completed clinical trials) may not have risen to a criminal or civil violation of law or regulation, it was clearly inappropriate, unprofessional and a direct threat to the integrity of the advisory committee process.
Congress turned down requests for an investigation and cited reasons for not looking into it that actually have no bearing on what the hearing would have and should have been about.
All the while, over 50,000 men have died from refractory (meaning beyond approved options and also beyond off label uses of approved drugs) AIPC.
This whole episode is vulgar.
Nathan
Tanin,
That’s a very good point. I wonder why Dendrion is holding back. The FDA has its hands tied due to confidentiality reasons. They cannot publicly reveal more info about the drug than the company has authorized. Therefore, all this attnention on the FDA may be misfocused. If Dendrion wants the drug approved, they should show everyone thier full deck of cards. So far, they haven’t.