Medical Forum / Diseases and Disorders / Prostate Cancer / September 2007
Rally for FDA Reform and Call for Congressional Action Provenge NOW
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Paul B - 05 Sep 2007 15:15 GMT I'm trying to find out if a ride-sharing system is being implemented to help get people to the 9/18 rally. I believe some financial assistance is available for cancer patients. p.
http://www.prnewsnow.com/PR%20News%20Releases/Legal%20And%20Law/A%20Right%20To%2 0Live%20Supporters%20to%20Rally%20for%20FDA%20Reform%20and%20Call%20for%20Congre ssional%20Action%20Provenge%20NOW
A Right To Live Supporters to Rally for FDA Reform and Call for Congressional Action Provenge NOW
A Right To Live ( http://www.arighttolive.com ), a cancer patient advocacy group formed to promote cancer patients' Right to Live through access to potentially life-saving therapies, today announces "A Right To Live Day" to be held September 18, 2007 from 10:00 am to 12:00 noon at the FDA offices in Rockville, MD.
The group will ask the FDA to immediately reconsider its flawed decision on Provenge, among others, and approve this new therapy for immediate use by late-stage prostate cancer patients with no viable alternatives. This new immunotherapy has already been endorsed by an FDA-appointed panel of experts who unanimously (17-0) determined it to be safe for its intended use. Further, the panel voted 13-4 in favor of the 'substantial evidence of efficacy' of Provenge, meeting the statutory requirements for immediate FDA approval. Never in its history had the FDA overturned a positive panel recommendation to deny terminal patients their right to live.
"It has become very clear over the past few years that the FDA has instituted a decelerated approval process for cancer therapies, in stark opposition to Congress' intent in legislating for accelerated approval pathways," said Scott Riccio, founding member and advocate for A Right To Live. The Wall Street Journal lamented this problem back in 2005, noting:
"The problem here is the FDA's unethical--and let us stress, unscientific--placebo-controlled trials, in which a subset of study patients are knowingly denied the new treatment and in some cases denied access to any active treatment at all. This may be moral with an antihistamine; it's certainly not with treatments for a terminal disease. What's more, it's entirely unnecessary. We already know what happens to most cancer patients who don't get treated. They die." (Wall Street Journal, March 24, 2005)
"There has never been such an incredible, irrational and unjustifiable denial of the rights of dying patients by such a dysfunctional agency," according to Mr. Riccio. "Approximately 27,000 men will die this year alone from late-state prostate cancer and tens of thousands of other cancer patients will lose their own fights against cancer this year while they wait in vain for new therapies to make their almost ten-year march from discovery to FDA review. We believe patients have a right to live. We're not asking for the FDA to forego scientific review, we're asking the Agency to catch up to the science that already exists and use it to approve and monitor these lifesaving new therapies while patients and their doctors get informed access to them. We hope that if the FDA continues to abdicate its duty to patients, Congress will make the necessary inquiries and legislative changes to reinstate a true accelerated approval process for them."
Patients, doctors, advocates, and other interested parties should visit http://www.arighttolive.com for more details on getting involved and supporting the public cry for immediate relief for the suffering of patients being denied their right to live.
The rally will be held at 5600 Fishers Lane, Rockville, Maryland, in front of the FDA's offices and will begin at 10:00 am. Featured speakers will include Mr. Frank Burroughs, co-founder of the Abigail-Alliance, Mr. Ray Matyshyn and Mr. Bruce Towers who are both Provenge clinical trials participants, and Mr. Charles Reinwald, President of Cancer Cure Coalition, Inc., along with other distinguished guests.
Who is A Right To Live
A Right To Live is an all-volunteer advocacy group formed in response to the FDA's refusal to follow the language and intent of Congress regarding an accelerated approval process for oncology drugs/therapies and the hundreds of thousands of patients dying while they wait for new therapies and options to make their way through the FDA's corrupted processes. We believe the review process employed by the FDA is not consistent with the law as written by Congress and as applied by current FDA reviewers is fundamentally broken. We believe that Provenge, Genasense, and Junovan should be approved now and would be but for an FDA system highlighted by aggressive incompetence, conflicts of interest, and an incorrect understanding of Congressional intent regarding the accelerated approval process as whole.
For media inquiries, please visit http://www.arighttolive.com or call Scott Riccio at 312-420-3296.
Steve Jordan - 05 Sep 2007 18:47 GMT (snip)
> A Right To Live ( http://www.arighttolive.com ), a cancer patient > advocacy group formed to promote cancer patients' Right to Live > through access to potentially life-saving therapies, today announces > "A Right To Live Day" to be held September 18, 2007 from 10:00 am to > 12:00 noon at the FDA offices in Rockville, MD. Well, so long as Paul wishes to post political propaganda from (primarily) investors in Dendreon and others who have filed suit against the FDA and at least one of its panel members, I'll post this:
> The answer, as far as I am concerned, is that Dendreon made major and > obvious mistakes in developing Provenge and not that the FDA is some [quoted text clipped - 4 lines] > In the end, they forced the FDA’s hand with their poor clinical trial > design.
> ...please think carefully about what you would use as a basis for > approval if you do not want to use the current criteria. After all, > is it really unreasonable to ask for proof that a drug is reasonably > safe and either improves survival or quality of life? This seems > pretty basic to me and is what I would ask as a patient myself. -- Charles E. Myers, Jr., MD Medical Oncologist PCa patient
From his bulletin "Prostate Forum" Volume 10 Number 2 www.prostateforum.com
Regards,
Steve J
Paul B - 05 Sep 2007 22:31 GMT > (snip) > [quoted text clipped - 33 lines] > > Steve J Steve, that is the argument from the other side. The argument from this side is that Provenge is the first of the oncoming immunotherapies, and it was not clear back then how best to test its efficacy. Thus it was forced into the paradigm of looking for time to progression, which is a surrogate for overall survival, rather than survival itself. The problem is that the surrogate works well for chemo, which hits hard and fast, but not for immunotherapies, which train the body to fight its own battles against cancer, a process which takes time.
Thus, the front end of the benefit curves for Provenge do not look wonderful, but the back ends, when the body begins to benefit from the training, does.
Yes, the tests have some troublesome elements. We've learned a lot about testing immunotherapies. The question now is whether Provenge should be held to the letter of the law, and thereby be penalized for what we didn't know several years ago when its tests were first designed, or whether we should be flexible in a space that is so badly underserved. Many of us believe that it makes no sense to withhold a treatment that all agree is safe.
Add to that the unbelievable conflicts of interest among those who most vocally opposed, and in an unprecedented way, the approval of Provenge, and you have a most interesting political scenario indeed.
Full disclosure - I have a small stake in Dendreon because I believe in the science and see the need, and I also have prostatitis. AISI, honest investors are vital to medical progress, and are disease sufferers' good friends. The FDA's denial of provenge was an abomination to humanitarianism and to a free people. p.
Steve Jordan - 05 Sep 2007 23:40 GMT On September 5, Paul B replied to me:
> Steve, that is the argument from the other side. And it is unanswerable.
> The question now is whether > Provenge (sic: Dendreon) should be held to the letter of the law, and thereby be > penalized for what we didn't know several years ago when its > tests were first designed Look again. Per Dr. Myers, Dendreon changed "endpoints midway through the clinical trial."
> or whether we should be flexible in a > space that is so badly underserved. Many of us believe that it > makes no sense to withhold a treatment that all agree is safe. But is it efficacious? That is the point at issue, and it is unproven.
Gobbling chocolate cake is safe (in moderation) but is it efficacious against my PCa?
> Add to that the unbelievable conflicts of interest among those > who most vocally opposed, and in an unprecedented way, the > approval of Provenge, and you have a most interesting political > scenario indeed. Ah yes, the scurrilous and "unbelievable" allegations that "conflicts of interest" somehow cause Dr. Harold Scher to write his famous letter to the FDA. BTW, to the extent there were conflicts or the appearance thereof, they were disclosed to and waived by the FDA.
One more time: the scurrilous attacks by Paul's fellow investors (there's the greed motive), primarily on Dr. Scher are an attempt to punish him for writing a letter to the FDA that is perfectly unassailable on the facts. Dr Scher now must defend himself from a vicious and unmerited lawsuit filed by, mainly, investors. Paul might be one of them for all I know. And I rather suspect that Paul might know the source of the death threats sent to Dr. Scher.
Uh, "science?" What's that? If anyone prevents me from making a profit on my investment, I'll make him suffer! The truth be damned!
> Full disclosure - I have a small stake in Dendreon Thanks. Any other conflicts of interest?
> because I believe in the science and see the need, And also want to make money.
> and I also have prostatitis. Well now. What does Provenge do for prostatitis? Nothing.
So why invest? Oh! To make money.
> The FDA's > denial of provenge was an abomination to humanitarianism and to a > free people. Was it good science? Answer: Yes. The rest is political polemics and of zero factual value.
There is no "humanitarianism" in foisting upon an unsuspecting public a tx that is unproven. The FDA exists to prevent that very thing!
The abomination in this matter is the injection of greed and politics into the field of scientific inquiry.
BTW, I'm as greedy as the next guy. But I didn't go bonkers when, frex, the very promising phenoxodiol was denied approval a few months ago. Oddly enough, because the manufacturer had erred in its clinical trial design. Sound familiar? It should.
Regards,
Steve J
"What are the facts? Again and again and again -- what are the facts? Shun wishful thinking, ignore divine revelation, forget 'what the stars foretell,' avoid opinion, care not what the neighbors think, never mind the unguessable 'verdict of history' -- what are the facts, and to how many decimal places? You pilot always into an unknown future; facts are your single clue. Get the facts!" --Lazarus Long
Paul B - 06 Sep 2007 00:49 GMT > On September 5, Paul B replied to me: > [quoted text clipped - 83 lines] > your single clue. Get the facts!" > --Lazarus Long You've jumped to plenty of innuendo here about my integrity, yet we've never met, to my knowledge. I'm in it for greed, I might have intimate knowledge of death threats, etc. Usually the one who jumps to smear his opponent by baseless innuendo is the one without a substantive argument.
Scher's most serious conflicts were in fact not disclosed to the FDA. For some examples, see today's op ed in the Bucks Co. Courier, copied below. Also see Scher's post advisory committee comments at http://blogs.wsj.com/health/2007/05/11/dendreons-ups-and-downs-at-fda-and-on-nasdaq and compare them with the reader comments that follow or, more concisely, to the .pdf file at http://caretolive.com/ScherOnThe4OfJuly.pdf.
There's plenty of troubling information out there that suggests that the FDA decision against Provenge was highly questionable.
p.
Congress must take action to end FDA abuses, conflicts By Theodore J. Cohen Theodore J. Cohen, Ph.D., is a research scientist
The so-called “Durbin Amendment,” Amendment SA 1034, was proposed in the U.S. Senate on May 9, 2007, to amend the Federal Food, Drug, and Cosmetic Act and, specifically, to ensure that participants in FDA advisory committees (AC) are free of financial conflicts of interest that would compromise their participation as unbiased Government employees.
Just what kind of situation might the Durbin amendment have protected against? Consider the recent case in which Dendreon Corporation brought its prostate cancer drug Provenge to an AC for review on March 29, 2007. One of the members of the AC was participating as a special Government employee under an approved waiver request in which he had first been required to declare his relevant conflicts of interest (COIs).
However, the COIs declared did not reveal the full extent of the conflicts. For example, they did not reveal that he was on Novacea, Inc.'s, scientific advisory board and is co-chair of the company’s ASCENT Phase III clinical trials investigating the use of Novacea’s Asentar drug together with Sanofi-Aventis’ chemotherapy drug Taxotere (docetaxel) to treat prostate cancer – a trial that some in the prostate cancer community believe would be adversely affected by Provenge approval. (Asentar is an oral treatment for prostate cancer.)
Further, he also is listed as a scientific advisor to ProQuest Investments., which owns a substantial interest in Novacea. Interesting, too, is the fact that in a highly unusual move for a special Government employee, this AC member wrote a letter to the FDA following the March 29th meeting, calling upon the agency not to approve Provenge.
More surprisingly, this letter was leaked by party or parties unknown to a non-peer-reviewed newsletter, and published in an obvious move to discredit the AC’s recommendation of approval (the AC voted 17-0 that the drug was safe and 13-4 that is demonstrated substantial efficacy). And finally, just three weeks after the FDA issued a Complete Response (CR) letter to Dendreon, asking for more data before it would approve Provenge, Schering Plough signed a $440 million deal with Novacea for the development of Asentar. What’s wrong with this picture?!
This is what the Durbin Amendment was meant to stop. “Was” is the operative word, because on May 9, 2007, the Amendment was rejected by a vote of 47 to 47, with 6 senators not voting. Senator Bob Casey (D, PA) voted “Yea;” Senator Arlen Specter (R, PA), for some inexplicable reason known only to him, voted “Nay.”
You’ll have to ask the senator why he rejected an amendment that was intended to stop egregious abuses such as that described above. But until Congress acts, we can expect more of the same from members of FDA ACs, who fail to reveal significant conflicts of interest before sitting in judgment of drugs that potentially could save the lives of tens of thousands of patients every year.
Steve Jordan - 06 Sep 2007 01:58 GMT > You've jumped to plenty of innuendo here about my integrity, yet > we've never met, to my knowledge. I'm in it for greed, I might have > intimate knowledge of death threats, etc. Usually the one who jumps > to smear his opponent by baseless innuendo is the one without a > substantive argument. Ah. It stings when the roles are reversed, doesn't it? But of course what I wrote that Paul complains about was neither baseless nor innuendo.
> Scher's most serious conflicts were in fact not disclosed to > theimpetus FDA. For some examples, see today's op ed in the Bucks Co. [quoted text clipped - 4 lines] > concisely, to the .pdf file at > http://caretolive.com/ScherOnThe4OfJuly.pdf. And blah blah blah. Were Scher's comments factual or not? No strained interpretations of his supposed impetus is relevant. So: Yes or no?
> There's plenty of troubling information out there that suggests that > the FDA decision against Provenge was highly questionable. Unless there are facts to support "troubling" suggestions that the FDA decision was "questionable" whatever that means, it's just so much lawn fertilizer. And so much innuendo in support of the profit motive.
And the verbiage Paul B attached to his last post is so much wasted space, having zero to do with evidence.
Regards,
Steve J
Epitaph for a wasted life:
"He lived beneath the moon And slept beneath the sun. He lived a life of going to do And died with nothing done." -- Anonymous
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